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Abstracts by Tom Swartz
A Study of Anti-CTLA4 Antibody in People with Advanced Synovial Sarcoma This Phase II is currently recruiting patients. The investigators of this study will try to exploit some of the proteins made by synovial sarcoma (cancer-germ cell or cancer-testis antigens) as targets for the immune system. Specifically, they will investigate if immune-based therapy with anti-CTLA4 antibody once every 4 weeks for three treatments will activate the immune system enough to attack recurrent synovial sarcoma. In this study the tumor itself will serve as the "vaccine" or source of protein to activate tumor-fighting T cells with the anti-CTLA4. Anti-CTLA4 takes the brakes off the immune system to allow otherwise hidden immune responses to become more active. In so doing, there could be other side effects, such as immune system attacks against the normal organs of the body. Thus, the investigators will follow both the anti-tumor immune responses with frequent blood tests and follow and treat side effects people develop on this study to determine if anti-CTLA4 is worth pursuing in a larger number of patients with synovial sarcoma or other sarcomas. Patients 18 years of age and older are eligible. The total expected enrollment is 17 patients. The trial started July 2005 and it is expected to be completed in March 2007. This study is taking place at Memorial Sloan-Kettering Cancer Center, New York.
Gefitinib in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma This Phase II trial is currently recruiting patients. The purpose of this trial is to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma. Gefitinib (also know as Iressa) belongs to a group of anticancer drugs called epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI). Gefitinib blocks growth signals in cancer cells. These signals are caused by an enzyme called tyrosine kinase. Gefitinib blocks several of these tyrosine kinases, including one associated with Epidermal Growth Factor Receptor (EGFR). EGFR is found on the cell surface of many normal cells and cancer cells. Gefitinib works by binding to the tyrosine kinase of the EGFR to directly block growth signals turned on by triggers outside or inside the cell. Patients receive oral gefitinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. A total of 14-44 patients will be accrued for this study within 18 months. Patients 18 years of age and older are eligible. This study is taking place at centers in Belgium, France, the Netherlands, and the United Kingdom.
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma This Phase II trial is not yet open for patient recruitment. Trastuzumab is a monoclonal antibody; it may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to study how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma. Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 weeks until disease progression and then every 6 months for up to 2 years from study entry. A total of 20-40 patients will be accrued for this study within 10-40 months. Patients 18 years of age and older are eligible. The location of this trial has not yet been announced.
This Phase II trial is currently recruiting patients. The purpose of this trial is to study how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery. Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses. A total of 15-30 patients will be accrued for this study. Patients 18 to 70 years of age are eligible. This trial is taking place at several centers in France.
Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas This phase II trial is not yet open for patient recruitment. Sorafenib is a "targeted drug" engineered to inhibit something called the RAF kinase within cancer cells. RAF in turn is part of the RAS oncogene pathway. RAS is a gene which drives cell division and is overexpressed in many cancers. In addition to targeting RAF kinase, Sorafenib also inhibits the VEGF and PDGF receptors on blood vessel cells. Thus, sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. The purpose of this trial is to study how well sorafenib works in treating patients with advanced soft tissue sarcomas, including angiosarcoma. Patients are stratified according to histology (leiomyosarcoma vs. liposarcoma vs. angiosarcoma, hemangiosarcoma, or hemangiopericytoma). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 6 months for 2 years and annually for up to 3 years. A total of 45-75 patients (15-25 per stratum) will be accrued for this study within 15-38 months. Patients 18 years of age and older are eligible. The location of this trial has not yet been identified.
Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma This Phase II trial is currently recruiting patients. Sorafenib is a "targeted drug" engineered to inhibit something called the RAF kinase within cancer cells. RAF in turn is part of the RAS oncogene pathway. RAS is a gene which drives cell division and is overexpressed in many cancers. In addition to targeting RAF kinase, Sorafenib also inhibits the VEGF and PDGF receptors on blood vessel cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. The purpose of this trial is to study how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma, including angiosarcoma. This is an open-label, non-randomized, multicenter study. Patients are stratified according to sarcoma histology (angiosarcoma vs. malignant peripheral nerve sheath tumor vs. leiomyosarcoma vs. high-grade undifferentiated pleomorphic sarcoma [i.e., malignant fibrous histiocytoma] vs. fibrosarcoma vs. all other types of sarcoma). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed at 4 weeks. A total of 222 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at centers in Illinois, Michigan, New York, Ohio, South Carolina, and Texas.
This Phase III trial is currently recruiting patients. The purpose of this trial is to compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs. without ifosfamide and pegfilgrastim as first-line therapy. Patients are stratified according to WHO performance status (0 vs. 1), age group (less than 50 years of age vs. 50 years of age and over), presence of liver metastases (yes vs. no), histological grade (2 vs. 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. The following sarcomas are eligible: malignant fibrous histiocytoma, myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma, pleomorphic rhabdomyosarcoma, synovial sarcoma, myxofibrosarcoma (intermediate and high-grade), fibrosarcoma, leiomyosarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, epithelioid sarcoma, alveolar rhabdomyosarcoma, unclassifiable sarcoma, not otherwise specified. A total of 450 patients will be accrued for this study within 4 years (study start 5/2003). Patients 18 to 60 years of age are eligible. This trial is taking place at centers in Austria, Belgium, Denmark, France, Germany, the Netherlands, Slovakia, Spain, and the United Kingdom.
This Phase I trial is currently recruiting patients. The purpose of this study is to test the safety of a vaccine that combines three drugs: GM-CSF, 1018-ISS and Telomerase Peptide Vaccine. GM-CSF and 1018-ISS are two drugs that are given to boost the body’s immune response against cancer cells. The study will also find out if the vaccine has any effect on your immune system. Eligible patients will be given injections of GM-CSF for the first three days. GM-CSF is a drug that helps increase the number and function white blood cells, which fight infection. On the fourth day, patients will be given a drug called 1018 ISS as an injection under the skin, which is being developed by Dynavax Technologies. On the fifth day, patients will be given the Telomerase Peptide Vaccine, also as an injection under the skin. The five-day vaccine cycles will be given every two weeks for two months and then every month for two months. During this time, patients will have frequent blood tests and medical checks to make sure they are doing well and to see if the study vaccine has any effect on their body and cancer. Patients may also undergo additional skin biopsies and scans to monitor their health. Participation in this trial may last up to 6 months and (1) as long as there are no serious side effects or progression of disease, or (2) until the patient chooses to withdraw. This trial is taking place at the Dana-Faber Cancer Institute, Boston, Massachusetts.
Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma This phase I/II trial is currently recruiting patients. Nelfinavir mesylate is a protease inhibitor which may help prevent cancer cells from spreading. The purpose of this trial is to study the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma. This is a phase I dose-escalation study followed by a phase II study. In the Phase I part of the study, patients receive oral nelfinavir mesylate twice daily in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of nelfinavir mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. In the Phase II part of the study, patients receive nelfinavir mesylate as in phase I at the MTD. A total of 40 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the City of Hope Comprehensive Cancer Center, Duarte, California.
This Phase II trial is currently recruiting patients. The purpose of this study is to provide access to treatment with trabectedin before the drug is commercially available and reimbursable to patients who previously received treatment for soft tissue sarcoma, who have relapsed or who are refractory to/intolerant of standard therapies. Trabectedin (ET-743, Yondelis) is the first of a new class of antitumor agents. Previous studies with trabectedin in patients who had been previously treated for soft tissue sarcoma have suggested that treatment with trabectedin resulted in tumor shrinkage, disease stabilization, and improved survival rates. However, hematologic toxicity, hepatic toxicity, and renal impairment were also observed in these patients. This is a single-arm, open-label, multicenter, study that is designed to provide access to trabectedin in patients with soft tissue sarcoma who are not expected to benefit from currently available therapeutic options for the treatment of soft tissue sarcoma. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment in patients previously treated for soft tissue sarcoma. Safety evaluation will include physical examinations, monitoring of vital signs and adverse events, and assessing clinical laboratory tests and 12-lead electrocardiogram results. Eastern Cooperative Oncology Group (scale used by researchers to represent the level of activity a patient is capable of) performance status will also be assessed. The treatment outline is as follows: 1.5 mg/m2 trabectedin reconstituted and diluted to 500 mL volume will be administered by central venous line over 24 hours at start of each 21-day treatment cycle; 20 mg dexamethasone, an anti-inflammatory agent, will be administered by vein 30 minutes before each trabectedin dose. The number of cycles will be response dependent. The total expected enrollment for this trial is 200 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Idaho, Illinois, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, South Carolina, and Canada.
This phase II trial is currently recruiting patients. The purpose of this study is to determine the antitumor activity of vinorelbine + cyclofosfamide in patients with a refractory tumor or in relapse in rhabdomyosarcomas and other soft part tissue tumors, Ewing’s tumors, osteosarcomas, neuroblastomas or medulloblastomas. The total expected enrollment is 210 patients (the study started in June 2003). Patients 12 months to 25 years of age are eligible. This study is taking place at the Institut Gustave-Roussy, Villejuif, France.
Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma This Phase III trial is not yet open for patient recruitment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma. Thus, the purpose of this trial is to study combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. The treatment outline is as follows:
In both groups, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 1½-3 months for 2 years, every 2-4 months for 2 years, every 6 months for 6 years, and then every 6-12 months thereafter. A total of 1,400 patients (630 good responders and 770 poor responders) will be accrued for this study within 4 years. Patients between 5 and 40 years of age are eligible. Patients who have received prior treatment for osteosarcoma are not eligible. The location of this trial is not yet identified.
This Phase II/III trial is currently recruiting patients. In 1986, St. Jude Children’s Research Hospital researchers initiated a trial (OS86) of ifosfamide, cisplatin, doxorubicin, and high-dose methotrexate. A subsequent trial (OS91), which was completed in 1997, substituted carboplatin for cisplatin. The 5-year survival estimates for patients with localized osteosarcoma were 69.2%±7.4% for those treated on OS86 and 73.1%±7.0% for those treated on OS91 (P=0.84). The results of OS91 demonstrated that the carboplatin and ifosfamide combination has substantial antitumor activity. When used with doxorubicin and high-dose methotrexate to treat localized osteosarcoma, this combination yielded outcomes comparable to those of trials using cisplatin-based therapy, with less long-term toxicity. On the basis of these results and the results of other studies that have eliminated high-dose methotrexate, St. Jude Children’s Research Hospital researchers are conducting this current trial to evaluate ifosfamide, carboplatin, and doxorubicin as an up-front therapy before surgery for localized and resectable osteosarcoma. The investigators believe that high-dose methotrexate may interfere with the dose-intensive delivery of the other agents, and thus, has been eliminated from this study. A total of 70 patients will be recruited for this study. Patients who have received prior chemotherapy are not eligible. Patients 25 years of age and younger are eligible. This trial is taking place at St. Jude Children's Research Hospital, Memphis, Tennessee.
This Phase II trial is currently recruiting patients. Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane are widely used drugs in the treatment of sarcomas. ImmTher is an investigational agent which stimulates the body's white blood cells to attack and kill tumor cells. The goal of this study is to see if treatment with vincristine, doxorubicin, cyclophosphamide and dexrazoxane (VACdxr) given in high doses with or without ImmTher will help patients with Ewing's sarcoma live longer. The safety of these treatments will also be studied. The total expected enrollment is 104 patients. Patients between 3 and 60 years of age are eligible. This trial is taking place at University of Texas M.D. Anderson Cancer Center, Houston, Texas.
This phase II trial is currently recruiting patients. It is open to patients that have histologically proven leiomyosarcoma of the uterus or other sites considered unresectable for cure. No previous chemotherapy is allowed, but patients may have received prior radiation provided it is completed >6 weeks prior to inclusion. It is a study of gemcitabine and docetaxel as a first line treatment. A total of 44 patients will be recruited. The trial is taking place in the United Kingdom. For further details, contact Jennifer Morrison (jennifer.morrison@rmh.nthames.nhs.uk).
This Phase III trial is currently recruiting patients. The purpose of this trial is to compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs. without ifosfamide and pegfilgrastim as first-line therapy. Patients are stratified according to WHO performance status (0 vs. 1), age group (less than 50 years of age vs. 50 years of age and over), presence of liver metastases (yes vs. no), histological grade (2 vs. 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. The following sarcomas are eligible: malignant fibrous histiocytoma, myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma, pleomorphic rhabdomyosarcoma, synovial sarcoma, myxofibrosarcoma (intermediate and high-grade), fibrosarcoma, leiomyosarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, epithelioid sarcoma, alveolar rhabdomyosarcoma, unclassifiable sarcoma, not otherwise specified. A total of 450 patients will be accrued for this study within 4 years (study start 5/2003). Patients 18 to 60 years of age are eligible. This trial is taking place at centers in Austria, Belgium, Denmark, France, Germany, the Netherlands, Slovakia, Spain, and the United Kingdom.
Bendamustin Hydrochloride in Patients with Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. Bendamustin is a bifunctional alkylating agent with low toxicity that produces both single and double strand breaks of DNA. It has show anti-tumor activity against Hodgkin’s and non-Hodgkin’s lymphomas, multiple myeloma, and chronic lymphatic leukemia. The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-based chemotherapy and to assess its toxicity. Patients 18 years of age and older are eligible. This trial is taking place at Medical center II, University of Tuebingen, Tuebingen, Germany.
ZD1839 and Oral Irinotecan in Treating Young Patients with Refractory Solid Tumors This Phase I trial is currently recruiting patients. The purpose of this trial is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose. The total expected enrollment is 30 patients. Patients up to 21 years of age are eligible. This trial is taking place at St. Jude Children's Research Hospital, Memphis, Tennessee.
UCN-01 and Irinotecan in Treating Patients With Metastatic or Unresectable Solid Tumors This Phase I trial is currently recruiting patients. Giving UCN-01 together with irinotecan may help kill more cancer cells by making tumor cells more sensitive to the drug. The purpose of this trial is to study side effects and best dose of giving UCN-01 together with irinotecan in treating patients with metastatic or unresectable solid tumors. This is a dose-escalation study. Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and UCN-01 IV over 3 hours on days 2 and 23. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 18-21 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at the Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri.
This Phase II trial is not yet open for patient recruitment. Pemetrexed disodium (Alimta) is a potent new antifolate which inhibits many folate-dependent reactions that are essential for cell proliferation. Its primary target is thymidylate synthase but it also inhibits folate-dependent enzymes involved in purine synthesis. Cells that are resistant to antifolates are generally less resistant to pemetrexed, irrespective of the mechanism of resistance. Pemetrexed has shown good activity in preclinical models with human tumor cells and xenografts. In the majority of clinical trials of pemetrexed, the dose-limiting toxic effect is neutropenia; other side-effects are mostly gastrointestinal. Preclinical studies indicate that the toxic effects of pemetrexed can be reduced by dietary folate, resulting in an improved therapeutic index. Low folate status is also associated with higher levels of toxicity in patients. As a single agent pemetrexed has shown good activity against non-small-cell lung cancer, squamous-cell carcinoma of head and neck, colon cancer, and breast cancer, and it appears to be particularly active in combination with cisplatin against non-small-cell lung cancer and mesothelioma. The purpose of this trial is to study how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma. Patients are stratified according to prior chemotherapy (yes vs. no). The treatment outline is as follows. Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity (NOTE: *The duration of course 1 is 28 days; the duration of all subsequent courses is 21 days). Beginning 7 days before the first dose of pemetrexed disodium and continuing until 21 days after the completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin B-12) intramuscularly once every 63 days and oral folic acid once daily. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients achieving a confirmed partial response (PR) that is resectable, proceed to surgical resection and then receive 2 additional courses of therapy after recovering from surgery. Patients achieving a confirmed PR that is not resectable continue treatment in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years. A total of 40-75 patients (20-40 in the previously treated stratum and 20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5 months. Patients 18 years of age and older are eligible. The location of this trial is not yet identified.
Study of Oral AP23573 to Treat Patients with Refractory or Advanced Malignancies This Phase I trial is currently recruiting patients. AP23573, being developed by Ariad Pharmaceuticals, Inc., is a mTOR inhibitor that starves cancer cells and shrinks tumors by regulating the response of tumor cells to nutrients and growth factors and by controlling tumor blood supply and angiogenesis through effects on vascular endothelial growth factor (VEGF) in tumor and endothelial cells. AP23573 is currently being studied in phase I and phase II clinical trials in patients with advanced cancers. Thus far, these trials have demonstrated that AP23573 has a favorable safety profile and possesses anticancer activity when administered as a 30-minute intravenous (IV) infusion daily x 5 every-two-weeks or on a weekly schedule. The primary objective of this current phase I trial, however, is to study the safety and tolerability of an orally administered dosage form of AP23573. This will be accomplished by an ascending dose study of 3 dosage regimens in patients with unresectable or metastatic cancer that is refractory to standard therapies. Patients 18 years of age and older are eligible. The expected total enrollment is 144 patients. This trial is taking place at the Cancer Therapy Research Center, San Antonio, Texas, and eventually at the Cancer Institute of New Jersey, New Brunswick, New Jersey.
FR901228 in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. FR901228 is a type of depsipeptide and belongs to the family of drugs called histone deacetylase inhibitors. Depsipeptide binds to and inhibits histone deacetylase, thereby affecting the regulation of gene expression and inducing cell differentiation, cell cycle arrest, and apoptosis. This agent also inhibits hypoxia-induced angiogenesis and depletes several HSP90-dependent oncoproteins. The purpose of this trial is to study how well FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma. Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR. After completion of study treatment, patients are followed every 2 months. A total of 18-36 patients will be accrued for this study within approximately 1 year. Patients 18 years of age and older are eligible. This study is taking place at centers in Arizona, California, Georgia, Illinois, Kentucky, North Carolina, Ohio, South Carolina, and Virginia.
This Phase I study is currently recruiting patients. The purpose of this clinical trial is to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in treating young patients who have recurrent or refractory leukemia or selected solid tumors, including rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma. Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 14, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD. Patients are followed for 30 days. A total of 70 patients (35 per stratum) will be accrued for this study within 23.3-35 months. Patients up to 21 years of age eligible. This study is being conducted at cancer centers in Arizona, Colorado, Florida, Georgia, Maryland, New York, Tennessee, and Texas.
This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects and best dose of giving 17-AAG together with bortezomib in treating patients with advanced solid tumors or lymphomas. This is a dose-escalation study. Patients receive 17-AAG IV over 1 hour and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 12 additional patients (6 patients with solid tumors and 6 patients with lymphoma) are treated as above* at the MTD. NOTE: *Bortezomib is not administered on day 1 of course 1 only. Patients are followed at 3 months. A total of 3-42 patients (3-36 with solid tumors and 6 with lymphoma) will be accrued for this study within 10.3 months-3.5 years. Patients 18 years of age and older are eligible. This trial is taking place at the Warren Grant Magnuson Clinical Center, Bethesda, Maryland and the Mayo Clinic Cancer Center, Rochester, Minnesota.
This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when given together with paclitaxel in treating patients with metastatic or unresectable solid tumor. This is a dose-escalation study of 17-AAG. Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose. A total of 6-35 patients will be accrued for this study within 2-11.7 months. Patients 18 years of age and older are eligible. This trial is taking place at the Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio and the Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. This phase I trial is studying the side effects, best way to give, and the best dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when given together with gemcitabine and/or cisplatin in treating patients with advanced solid tumors. This is a dose-escalation, cohort study of 17-AAG. Patients are assigned to 1 of 3 treatment cohorts as follows: (Note: Cohort A closed to accrual as of 3/2/04; Cohort B closed to accrual as of 3/2/05).
NOTE: ** Gemcitabine and cisplatin dosage is constant, while 17-AAG is escalated in cohorts B, C, and D. NOTE: *** Gemcitabine dosage is constant, 17-AAG is started at a higher dose level than all other cohorts, and cisplatin dosage is escalated in cohort E. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. In all cohorts, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 months. A total of 12 patients have been accrued for part I (cohort A closed to accrual as of 3/2/04) of this study. An additional 33-66 patients will be accrued for part II (cohorts B [closed to accrual as of 3/2/05], C, D, and E) of this study within approximately 3 years. Patients 18 years of age and older are eligible. This trial is taking place at the Mayo Clinic Cancer Center, Rochester, Minnesota.
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors This Phase I trial is currently recruiting patients. The purpose of this trial is to study the side effects and best dose of combination chemotherapy 17-AAG and docetaxel in treating patients with metastatic or unresectable solid tumors. This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). This is a dose-escalation study of 17-AAG. Patients are assigned to 1 of 2 treatment groups as follows:
Cohorts of 3-6 patients per group receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 20 additional patients (10 per group) are treated at the MTD. Approximately 33-96 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York and the Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
This Phase II trial is currently recruiting patients. This trial will use the drugs tasonermine (TNFa) and melphalan in the treatment of locally advanced sarcoma of the pelvis and limbs’ girdle using isolated pelvic perfusion. Isolated pelvic perfusion allows for administration of chemotherapy agents solely to the pelvic region by isolating the pelvic vasculature with occlusion of the large abdominal vessels with intra-vascular balloons and external thigh tourniquets. This technique allows for the administration of higher doses with the hope of greater efficacy. Patients with resectable tumors are not eligible. The total expected enrollment is 33 patients. Patients 16 years of age and older are eligible. This trial is taking place at the Institut Gustave-Roussy, Villejuif, France.
This Phase II trial is currently recruiting patients. The purpose of this study is to explore how sarcomas are affected by a new medication, cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor receptor), that is found in some types of cancer. Studies have shown that this drug can be beneficial in patients with colon cancer and has been approved by the US Food and Drug Administration (FDA) for this purpose. The investigators are conducting this study to see if it is beneficial in patients with sarcoma. Patients with unresectabale or metastatic high grade soft tissue or bony sarcoma 16 years of age and older are eligible. This trial is taking place at the University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
Stem Cell Transplantation for Metastatic Solid Tumors This Phase II trial is currently recruiting patients. The goal of this study is to identify types of cancer that may be treatable with stem cell transplantation. Patients with a variety of different types of cancerous tumors, including sarcoma, that have metastasized and whose conditions have not improved with stand therapy, will be eligible to participate. Patients selected to participate in the study will undergo a procedure known as a "mini-transplant". The mini-transplant is a transplantation of stem-cells collected from a sibling (brother or sister) of the patient. Unlike traditional bone marrow transplants, the mini-transplant does not require intense chemotherapy or radiation therapy. Because of this, patients experience fewer and less severe side effects. The total expected enrollment is 150 patients. Patients 10 to 80 years of age are eligible. This study is taking place at the National Heart, Lung and Blood Institute, Bethesda, Maryland.
Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas This Phase I trial is currently recruiting patients. This study will examine the safety and effectiveness of stem cell transplantation for treating patients with sarcomas. Stem cells are immature cells in the bone marrow and blood stream that develop into blood cells. Stem cells transplanted from a healthy donor travel to the patient's bone marrow and begin producing normal cells. In patients with certain cancers, such as leukemia and lymphoma, the donor's immune cells attack the patient's cancer cells in what is called a "graft-versus-tumor" effect, contributing to cure of the disease. This study will determine whether this treatment can be used successfully to treat patients with sarcomas. Patients between 4 and 35 years of age with a sarcoma that has spread from the primary site or cannot be removed surgically, and for whom effective treatment is not available, may be eligible for this study. Candidates must have been diagnosed by the age of 30 at the time of enrollment. They must have a matched donor (usually a sibling). Participants undergo the following procedures:
After hospital discharge, patients are followed in the clinic at least once or twice weekly for a medical history, physical exam, and blood tests for 100 days. They receive medications to prevent infection and GVHD and, if needed, blood transfusions. If GVHD has not developed by about 120 days post transplant, patients receive additional white cells to boost the immune response. After 100 days, follow-up visits may be less frequent. Follow-up continues for at least 5 years. During the course of the study, patients undergo repeated medical evaluations, including blood tests and radiology studies, to check on the cancer and on any treatment side effects. On four occasions, white blood cells may be collected through apheresis to see if immune responses can be generated against the sarcomas treated in this study. Positron emission tomography (PET) scans may be done on five occasions. The total expected enrollment is 96 patients. This study is taking place at the National Cancer Institute, Bethesda, Maryland.
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors This Phase I trial is currently recruiting patients. Radiolabeled octreotide can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Thus, the purpose of this trial is to study the effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors. This is a dose-escalation study. Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1. Treatment repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of yttrium Y 90-DOTA-tyr3-octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly after each treatment course, 6 weeks after the last course, and then every 6 months thereafter for life. Approximately 25-35 patients will be accrued for this study. Patients age 2 to 25 years old are eligible. This trial is taking place at the Holden Comprehensive Cancer Center at the University of Iowa, Iowa City, Iowa.
V2N6 ESUN Copyright © 2005 Liddy Shriver Sarcoma Initiative.
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