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Clinical Trial News
Annotations by Tom Swartz
Clinical Trials Open to Malignant Fibrous Histiocytoma Patients This Phase II trial is currently recruiting patients. The purpose of this trial is to study the effectiveness of imatinib mesylate, also known as Gleevec, in treating patients who have locally recurrent or metastatic adult soft tissue sarcoma, including malignant fibrous histiocytoma. Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses. Patients are followed every 6 months for 2 years and then annually for 3 years. A total of 20-40 patients will be accrued for this study within 10 months-3.4 years. Patients 18 years of age and older are eligible. This a large multi-center study taking place in many states.
This Phase II trial is currently recruiting patients. The purpose of this trial is to study the effectiveness of imatinib mesylate, also known as Gleevec, in treating patients who have locally recurrent or metastatic adult soft tissue sarcoma, including malignant fibrous histiocytoma. Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression. Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter. A total of 44 patients will be accrued for this study within 2 years. Patients 18 years of age and older are eligible. This study is taking place at centers in Belgium and the Netherlands.
This Phase I trial is currently recruiting patients. The purpose of this trial is to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma, including malignant fibrous histiocytoma. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 or on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. A total of 3-24 patients will be accrued for this study. Patients 18 to 70 years of age are eligible. This study is taking place at centers in Denmark and Germany.
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma This Phase II trial is currently recruiting patients. The purpose of this trial is to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma, including malignant fibrous histiocytoma. Patients are stratified according to histological diagnosis (leiomyosarcoma vs. other histologies). Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival. A total of 32-50 patients (16-25 per stratum) will be accrued for this study. Patients 15 to 75 years of age are eligible. This study is taking place at centers in Belgium, Denmark, Germany, and Slovakia.
This Phase III trial is currently recruiting patients. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not known whether receiving chemotherapy plus hyperthermia is more effective than receiving chemotherapy alone in treating patients with soft tissue sarcoma. Thus, the purpose of this trial is to compare the effectiveness of combination chemotherapy with or without hyperthermia therapy in treating patients with soft tissue sarcoma, including malignant fibrous histiocytoma. Patients are stratified according to risk category and disease site (extremity vs. nonextremity). Patients are randomized to one of two treatment arms. In Arm I: Patients receive etoposide IV over 30 minutes on days 1 and 4, ifosfamide IV over 60 minutes on days 1-4, and doxorubicin IV over 30 minutes on day 1. Treatment continues every 21 days for a total of 4 courses. Patients also undergo regional hyperthermia. In Arm II: Patients receive chemotherapy alone as in arm I. Patients in both arms undergo definitive surgery 4-6 weeks after chemotherapy. Patients also undergo radiotherapy beginning 4-6 weeks after surgery. After completion of surgery and radiotherapy, patients with non-resectable tumors showing no disease progression receive an additional 4 courses of chemotherapy with or without regional hyperthermia according to above treatment schedule. A total of 340 patients (170 patients per arm) will be accrued for this study. Patients 18 to 70 years of age are eligible. This study is being conducted at several centers in Germany.
This Phase III trial is currently recruiting patients. It is not yet known whether doxorubicin is more effective with or without ifosfamide in treating soft tissue sarcoma. Thus, the purpose of this trial is to compare the effectiveness of doxorubicin with or without ifosfamide in treating patients who have locally advanced or metastatic soft tissue sarcoma, including malignant fibrous histiocytoma. 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.
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. A total of 450 patients will be accrued for this study within 4 years. Patients 18 to 60 years of age are eligible. This study is taking place at centers in Belgium, Denmark, France, Germany, Netherlands, Slovakia, Spain, and the United Kingdom.
This Phase III trial is currently recruiting patients. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy. Thus, the purpose of this trial is to compare the effectiveness of surgery with or without radiation therapy in treating patients who have primary soft tissue sarcoma, including malignant fibrous histiocytoma, of the retroperitoneum or pelvis. Patients are stratified according to tumor grade (low [G1] vs. intermediate [G2] vs. high [G3/4]), tumor size (< 15 cm vs. ≥ 15 cm), and tumor histology (liposarcoma vs. non-liposarcoma). Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years. A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years. Patients 18 years of age and older are eligible. This study is taking place at the MD Anderson Cancer Center at University of Texas, Houston, Texas.
Additional Clinical Trials Open to Sarcoma Patients EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal Cancer This diagnostic trial is currently recruiting patients. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy. The purpose of this trial is to study the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients who have intra-abdominal cancers, including sarcoma. Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined. Patients are followed at 2-6 weeks. A total of 20 patients will be accrued for this study within 10-12 months. Patients 18 years of age and older are eligible. This study is taking place at the Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania
A Study of ET743 in Subjects With Advanced Liposarcoma or Leiomyosarcoma This Phase II trial is currently recruiting patients. The purpose of this trial is to study the safety and effectiveness of the investigational chemotherapy agent ET743 in subjects with advanced liposarcoma or leiomyosarcoma. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation of the trial protocol can be provided by the investigator conducting the study. Patients 18 years of age and older are eligible. This trial is taking place at centers in California, Colorado, The District of Columbia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Utah, Washington, and Wisconsin.
Two Dose Schedules of Panitumumab in Subjects with Advanced Solid Tumors This Phase I trial is currently recruiting patients. The purpose of this trial is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors. Patients 18 years of age and older are eligible. This trial is taking place at centers in Colorado, Minnesota, North Carolina, and Texas.
Study Evaluating AMG 386 in Adult Patients with Advanced Solid Tumors This Phase I trial is currently recruiting patients. The purpose of this study is to test the safety, tolerability and pharmacokinetic profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors. Patients 18 years of age and older are eligible. This trial is taking place in California.
Tolerability Study of Investigational Agent, ARRY-142886, in Patients with Cancer This Phase I trial is currently recruiting patients. The purpose of this trial is to assess the tolerability of ARRY-142886 in patients with advanced solid malignancies that have failed standard therapy or for whom no standard therapy exists and determine the maximum tolerated dose as defined by significant dose limiting toxicity. Patients 18 years of age and older are eligible. This trial is taking place in Colorado and Minnesota.
This trial is currently open for enrollment. The purpose of this trial is to see how different schedules of drugs can prevent the spread of soft tissue cancer of the arm or leg after surgery. Persons with recently diagnosed soft tissue sarcoma of an arm or leg may be eligible to participate. Soon after the sarcoma is found, participants will have blood tests. Then they will get chemotherapy through a vein once a month for two months before surgery. They will get GM-CSF (a drug that encourages the growth of blood cells) under the skin twice a day for 4 days before and 14 days after getting the cancer drugs. Then radiation treatment begins. During radiation therapy, they will get mitomycin, doxorubicin, and cisplatin together twice into a vein. They will also take a GM-CSF mist every other week during radiation and every other week for 5 more weeks beginning one month before surgery and ending 10 weeks later. Researchers will teach them how to give themselves aerosol and GM-CSF shots. Study participants will have blood tests before each cycle of chemotherapy, weekly between cycles of chemotherapy, before surgery, and at 4 and 14 weeks after surgery. During follow-up, they will have blood tests every 3 months during the first year, every 4 months the second year, every 6 months the third and fourth years, and at the fifth year of follow-up. The treatment part of the study can last up to 30 weeks. Follow-up appointments will continue for at least 10 years. This trial is being conducted at the Mayo Clinics in Rochester, Minnesota, Jacksonville, Florida, and Scottsdale and Phoenix, Arizona.
A Trial of 17-AAG to Treat Solid Tumors [Information no longer available online 10/2005] This trial is currently open for enrollment. The purpose of this study is to learn the highest safe dose of 17-allylaminogeldanamycin (17-AAG) given twice a week as a treatment for advanced cancer. Researchers also want to learn about how the body responds to and removes the study drug, and about its side effects. Patients with advanced cancer may be eligible to participate. During the first week of treatment, researchers will collect blood, urine, and tissue samples. Additional blood and tissue tests will be done during the first month. Those whose tumors can be safely and easily biopsied may be asked to have two additional biopsies: one before and one after the first dose. Study participants will have blood tests at least once a week. During the study, participants will get 17-AAG through a vein twice a week for two weeks, and then have a week off. As long as they have no serious side effects and their cancer gets no worse, they can continue getting the study drug on the same schedule (two weeks on, one week off). Participants will be in the study for 3 months after the last dose of the study drug. This trial is being conducted at the Mayo Clinic in Rochester, Minnesota.
Trial of OSI-774 and CPT-11 to Treat Advanced Solid Tumors This trial is currently open for enrollment. The purpose of this study is to find the highest safe dose of the two cancer drugs OSI-774 and CPT-11 that can be given on a 3-week schedule. Researchers also want to determine the side effects of OSI-774 and CPT-11 when they are given together and the drugs’ effects in the body. Patients who have advanced solid tumors may be eligible to participate. One week before the start of the first 3-week cycle, and daily until end of study, participants will swallow one dose of OSI-774 every morning. On day 1 of each cycle — that is, once every three weeks — participants will receive CPT-11 intravenously. Participants in an earlier study got various doses of these two study drugs, and researchers now think that the dose offered in this part of the study is the maximum tolerated. Thus, all participants in this part of the study will get the same doses, and all will be watched carefully for side effects. During the study, participants will have blood tests at least once a week. The size of the tumor will be checked by CT scan or MRI every 3-6 weeks. As long as the tumor gets no worse and a participant has no bad side effects, OSI-774 daily and CPT-11 every 3 weeks can be repeated. Researchers will follow participants’ health status for up to 3 months. This trial is being conducted at the Mayo Clinic in Rochester, Minnesota.
V2N2 ESUN Copyright © 2005 Liddy Shriver Sarcoma Initiative
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