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Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors Clinical research trials and Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors. Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors  Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
For Condition: recurrent testicular cancer,extragonadal germ cell tumor
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow transplantation is a more effective treatment for men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with bone marrow transplantation in treating men with relapsed germ cell tumors.
Details: OBJECTIVES: I. Compare the event-free survival of male patients with germ cell tumors in relapse or first partial remission treated with salvage therapy comprising cisplatin, etoposide, and ifosfamide (PEI) or vinblastine, ifosfamide, and cisplatin (VeIP) with or without high-dose carboplatin, etoposide, and cyclophosphamide, followed by autologous bone marrow and/or peripheral blood stem cell transplantation. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior complete remission to first-line treatment (yes vs no), primary site of disease (testicular vs retroperitoneal vs mediastinal), and lung metastases at study entry (yes vs no). Autologous bone marrow and peripheral blood stem cells (PBSC) are harvested. Part I (salvage): Patients are assigned to regimen A if they previously received vinblastine as part of a first-line treatment, such as cisplatin, vinblastine, and bleomycin (PVB) or cisplatin, cyclophosphamide, doxorubicin, vinblastine, and bleomycin (CISCA VB). Patients are assigned to regimen B if they previously received etoposide (VP-16) as part of a first-line treatment, such as bleomycin, VP-16, and cisplatin (BEP). Regimen A: Patients receive cisplatin IV over 2 hours, VP-16 IV over 2 hours, and ifosfamide IV over 1 hour on days 1-5 (PEI). Regimen B: Patients receive cisplatin and etoposide as in regimen A and vinblastine IV on days 1 and 2 (VeIP). Treatment on both regimens continues every 3 weeks for 2 courses. Patients with refractory disease at day 43 are taken off study. Part II: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive 2 additional courses of PEI or VeIP. Arm II: Patients receive 1 additional course of PEI or VeIP, followed by 1 course of high-dose carboplatin IV over 2 hours, VP-16 IV over 2 hours, and cyclophosphamide IV over 1 hour on days 1-4. Autologous bone marrow and/or PBSC are reinfused on day 7 of the fourth course for patients on both arms. Patients on both arms with residual disease after the fourth course may undergo surgery. PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of testicular or extragonadal male germ cell tumors; Must meet 1 of the following conditions after completion of platinum-based first-line chemotherapy: Complete remission (CR) followed by relapse; Partial remission (PR); Prior resection of viable malignancy with elevated tumor markers allowed - Initial bulky disease with no CR (significantly reduced but still abnormal in plateau) allowed if there is an increase in biological tumor markers or development of new metastases - Seminoma with relapse after CR or PR to cisplatin-based chemotherapy allowed - No pure seminoma pre-treated with carboplatin - No refractory disease (i.e., documented increase in tumor burden and/or serum tumor marker level during or within 1 month after platinum-containing chemotherapy) - CNS involvement allowed --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy for metastatic disease allowed - Surgery: See Disease Characteristics; Prior surgery for metastatic disease allowed --Patient Characteristics-- - Age: 16 and over - Sex: Male - Performance status: WHO 0-2 OR Karnofsky 50-100% - Life expectancy: No limits on life expectancy due to severe non-malignant disease - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No severe cardiac disease that would interfere with study therapy - Pulmonary: No severe pulmonary disease that would interfere with study therapy - Other: HIV negative; No severe neurologic or metabolic disease that would interfere with study therapy; No psychological, socioeconomic, or geographic circumstances that would preclude study; No other concurrent malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Jose-LouisPico, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Institut Gustave Roussy
Villejuif, , F-94805
France
Additional Information:
Study ID Numbers: CDR0000063579; FRE-IT94,NCI-F94-0019,FRE-FNCLCC-IT94
Study Start Date: February 1994
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002566
Other Recurrent Testicular Cancer Studies:
1. Arsenic Trioxide in Treating Men With Germ Cell Cancer
2. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
3. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors
4. Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer
5. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Related Studies:
Other recurrent testicular cancer Clinical Trials
Other Clinical Trials
Other Villejuif Clinical Trials
Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
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