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Clinical Trial News
Annotations by Tom Swartz
[Editor's Note: We have made a substantial change in the way in which we are providing clinical trial information in ESUN and on our website. Because the Clinical Trial News column is so highly accessed, we have reduced the need for you to "search" back issues of ESUN to locate clinical study information. We have created three separate webpages where all of the clinical trial information that we have published in ESUN to date has been collected. You can read about these changes in the editorial, Changes Made, in this issue.]
Currently Accepting Eligible Patients (not previously published in ESUN)
This Phase II trial is currently recruiting patients. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy to the tumor area only may kill more tumor cells and cause less damage to healthy tissues. This trial is studying isolated limb infusion of chemotherapy to see how well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg that cannot be removed by surgery. Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity. After the limb is warmed, melphalan and dactinomycin are rapidly infused into the isolated limb via the arterial catheter. Melphalan and dactinomycin are then recirculated for 20 minutes. Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician. Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months thereafter as deemed necessary by the treating physician. A total of 35 patients will be accrued for this study within 3 years. Patients 18 years of age and older are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York.
Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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. This trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma. Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. A total of 41 patients will be accrued for this study. Patients up to 17 years of age are eligible. This trial is taking place at many centers in Japan.
This Phase I trial is currently recruiting patients. Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and leucovorin, 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. This trial is studying the side effects and best dose of trimetrexate glucuronate when given together with methotrexate and leucovorin in treating patients with refractory or recurrent osteosarcoma. This is a dose-escalation study of trimetrexate glucuronate. Patients receive high-dose methotrexate IV over 4 hours on days 1 and 8 and oral trimetrexate glucuronate twice daily on days 2-6 and 9-13. Patients also receive leucovorin calcium IV continuously over 24 hours or orally 2 or 4 times daily on days 9-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of trimetrexate glucuronate 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 maximum of 18 patients will be accrued for this study within 2 years. Between 1 and 35 years of age are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York.
This diagnostic trial is currently recruiting patients. Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment. This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma. This is a prospective, pilot study. The objectives of the study are (1) Determine whether an FDA-approved device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma; (2) Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment; (3) Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately; (4) Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival; (5) Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery. Patients are stratified according to disease (high-grade soft tissue sarcoma vs. low-grade soft tissue sarcoma vs. osteosarcoma). Patients undergo fludeoxyglucose ^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans). A total of 120 patients will be accrued for this study. Patients 18 years of age and older are eligible. This trial is taking place at Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California.
This Phase II trial is currently recruiting patients. This is a study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. The purpose is to determine if an injection of the patient’s own immune related white blood cells into their tumor will strengthen the immune system to fight against their cancer. Pre-treatment test will consist of a blood draw for anti-tumor immune response and Hepatitis B, Hepatitis C, HIV tests. A biopsy with collection of tumor cells. Assays (ELISPOT and flow cytometry) to test for the intended anti-tumor cell T cell response will be performed on biopsy specimens as well as standard pathology department review of specimens for diagnosis and assessment of necrosis and apoptosis. Labs will also be drawn for surgical specimens and post-therapy immunity assays. Prior to commencing therapy, a procedure called leukapheresis (peripheral blood mononuclear cell) isolation will be conducted and twenty-four hours prior to intended injection, the dendritic cells will be harvested and assessed for quality control. Prior to injection (the clinical target is the gross tumor), history and physical examination will be performed. Toxicity will be assessed according to CTC criteria. The plan will be to inject the entire dendritic cell product evenly throughout the tumor. Conventional therapy consists of external beam radiation therapy, 25 fractions from day 1-33 administered Monday through Friday only. The experimental therapy, dendrite cell (DC) injections will occur during the course of the external beam radiation therapy. DC injections will be prepared from frozen white blood cells and injected at four intervals on day 12, 19, 26, and day 33. DCs will be labeled (with a radioisotope) and injected intratumorally before surgery. You will be randomized into one of three groups. One group will receive injection of labeled DCs 72 hrs before surgery, second group – 48 hrs, and third group 24 hrs before surgery. Surgery will occur on day 50 for tumor removal. If the experimental treatment causes a measurable change in the immune blood tests, there will be office visits, every 3 months for 2 years. In the longer term, there will be office visits at 6 month intervals for the third year, and yearly thereafter. A CT scan of chest and MRI scan of extremity will be performed at every office visit. The total expected enrollment is 22 patients. This trial is taking place at the H Lee Moffitt Cancer Center & Research Institute, Tampa, Florida.
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor This Phase I trial is currently recruiting patients. Gimatecan® is Sigma-Tau Research’s new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. This study is being conducted to study to determine the Maximum Tolerated Dose of Gimatecan® when given as a capsule, rather than by intravenous injection. Further study details as provided by Sigma-Tau Research, Inc. The total expected enrollment is 30 patients. Patients 18 years of age and older with solid tumors are eligible. This trial is taking place at centers is Massachusetts and Rhode Island.
Study of Dasatinib in Patients With Advanced Solid Tumors This Phase I trial is currently recruiting patients. The purpose of Segment 1 of this study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors. Further study details as provided by Bristol-Myers Squibb are as follows:
The total expected enrollment is 60 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Florida, Tennessee, and Texas.
Phase I (PH I) Mad Refractory Solid Tumor Study This Phase I trial is currently patients. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect of food, and continue exploratory research of BMS-354825 in patients with solid tumors not responding to standard treatment, or for which no effective standard treatment exists. Patients 18 years of age and older are eligible. This trial is taking place at centers in Massachusetts, Michigan, and the United Kingdom.
This Phase I trial is currently recruiting patients. VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the tumor. This phase I trial is thus studying the side effects and best dose of intravenous VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. This is an open-label, dose-escalation, multicenter study. Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses. Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6 patients are treated at that dose level. In the absence of dose-limiting toxicity, patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol. Patients are followed at weeks 1, 3, and 7 and then at 3 months. A maximum of 25 patients will be accrued for this study. Patients 18 years or age and older are eligible. This trial is taking place at Memorial Sloan-Kettering Cancer Center, New York.
Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma This Phase II trial is currently recruiting patients. The purpose of this study is to assess the overall response rate (ORR) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501. The total expected enrollment is 30 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Arizona, California, New York, and Pennsylvania.
This Phase I trial is currently recruiting patients. This study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag administered with ADRIAMYCIN and ifosfamide (AI) chemotherapy in subjects with sarcoma who have a low platelet count. The total expected enrollment is 65 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Pennsylvania and Texas.
Phase I/II Study of Gemcitabine, Docetaxel and Bevacizumab in Patients With Soft Tissue Sarcoma This Phase I/II trial is currently recruiting patients. Bevacizumab is an antiangiogenesis agent. Because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, the investogators of this trial hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types. Thus, the purpose of this trial is: (1) To determine the recommended phase II dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab; (2) To determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma; (3) To determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma. Patients 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease. Prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures. The total expected enrollment is 30 patients. This trial is taking place at several centers in New Mexico.
This Phase II trial is currently recruiting patients. Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim may kill more tumor cells. This trial is studying how well giving docetaxel and gemcitabine together with G-CSF or pegfilgrastim works in treating patients with advanced, persistent, or recurrent uterine leiomyosarcoma. This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs. no). Patients receive gemcitabine IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 9-15 OR pegfilgrastim SC on day 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. A total of 12-43 patients will be accrued for this study within 12-28 months. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Connecticut, Delaware, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, and Wisconsin.
Not Yet Recruiting Patients (not previously published in ESUN)
This Phase III trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as vincristine, dactinomycin, cyclophosphamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma. The purpose of this trial is to study two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. This is a prospective, historic control, randomized, multicenter study. Patients are stratified according to histology, disease stage, and clinical group (group III, stage 2 or 3 embryonal rhabdomyosarcoma [RMS] vs. group I, stage 1 alveolar RMS vs. group II or III, stage 2 or 3 alveolar RMS). Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery or biopsy:
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients* in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 (except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression). NOTE: *Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients ≤ 24 months of age. After completion of study treatment, patients are followed periodically for ≥ 10 years. A total of 486 patients will be accrued for this study. Patients up to 50 years of age are eligible. The location of this trial is not yet identified.
This Phase IIIb
trial is not yet open for patient recruitment.
This is a Phase IIIb study of patients
with gastrointestinal stromal tumors who have had progressive disease
while on 400 mg imatinib. Patients will be randomly assigned to either
sunitinib 37.5 mg daily or Imatinib 800 mg daily. This study will find out
the benefits and potential side effects of taking sunitinib or imatinib for
one year. The primary outcome of the trial is to evaluate the duration of
progression free survival (PFS) on sunitanib or imitanib. PFS is defined as
the time from date of first treatment dose to progression of the
gastrointestinal stromal tumor or death for any reason, whichever comes
first.
This Phase II trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The purpose of this trial is to study how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus. This is a nonrandomized, multicenter study. Patients receive trabectedin IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses. After completion of study treatment, patients are followed every 3 months. A total of 43 patients will be accrued for this study. Patients 18 years of age and older are eligible. The locations of this trial are not yet identified.
Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus This Phase II trial is not yet open for patient recruitment. Sunitinib 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. This trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. A total of 44 patients will be accrued for this study. Patients 18 years of age and older are eligible. The locations of this trial are not yet identified.
This Phase III trial is not yet open for patient recruitment. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen is more effective in treating soft tissue sarcoma. The purpose of this trial is to study observation to see how well it works compared with radiation therapy, combination chemotherapy, and/or surgery in treating patients with soft tissue sarcoma. This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs. no), status of prior surgery (resected vs. unresected), grade of tumor (low vs. high), and size of primary tumor (≤ 5 cm vs. > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs. metastatic), tumor size (≤ 5 cm vs. > 5 cm), extent of resection of primary tumor (resected vs. unresected), extent of resection of metastases (complete or microscopic residual vs. gross residual), microscopic tumor margins (negative vs. positive), and tumor grade (low vs. high).
NOTE: *Patients with primary hepatic tumors do not receive radiotherapy in week 4.
NOTE: *Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19.
In all groups, treatment continues in the absence of disease progression. After completing study treatment, patients are followed periodically for at least 5 years. A total of 865 patients will be accrued for this study. Patients up to 29 years of age are eligible. The locations of this trial are not yet identified.
This Phase I trial is not yet open for patient recruitment. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. The purpose of this trial is to study the side effects and best dose of AZD2171 in treating young patients with refractory or recurrent solid tumors or acute myeloid leukemia. This is an open-label, dose-escalation study. Patients are stratified according to diagnosis (solid tumor vs. acute myeloid leukemia
Cohorts of 3-6 patients receive escalating doses of AZD2171 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 during the first course of therapy. Up to 9 patients, preferably at least 3 patients < 12 years of age and at least 3 patients ≥ 12 years of age, are treated at the MTD.
Patients undergo blood collection periodically during study for pharmacologic and pharmacodynamic correlative studies. A total of 33 patients will be accrued for this study. Patients between 2 and 18 years of age are eligible. The location of this trial is not yet identified.
This Phase III trial is not yet open for patient recruitment. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, and topotecan, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating Ewing's sarcoma. The purpose of this trial is to study combination chemotherapy and topotecan to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed localized Ewing's sarcoma. This is a randomized, multicenter study. Patients are stratified according to age (≤ 17 vs. ≥ 18 years of age) and primary tumor site (pelvic vs. nonpelvic [including extra-osseous Ewing's sarcoma]). Patients are randomized to 1 of 2 treatment arms:
After completion of study treatment, patients are followed periodically for 5 years. A total of 528 patients will be accrued for this study. Patient up to 50 years of age are eligible. The location of this trial is not yet identified.
This Phase III trial is not yet open for patient recruitment. This trial is for patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or Imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for one year. The total expected enrollment is 212 patients and the study is expected to start in November 2006. Patients 18 years of age and older are eligible. To obtain contact information for a study center near you, click here.
This Phase IV trial is not yet open for patient recruitment. The purpose of the study is to achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase. Patients 6 months to 21years of age with non-metastatic rhabdomyosarcoma are eligible. Further study details as provided by the Sheba Medical Center – click here.
V3N5 ESUN Copyright © 2006 Liddy Shriver Sarcoma Initiative. |
Registered
in ClinicalTrials.gov: NCT00354848
