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Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002566
  Purpose

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.


Condition Intervention Phase
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: ifosfamide
Drug: vinblastine
Procedure: autologous bone marrow transplantation
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer   

ChemIDplus related topics:   Ifosfamide    Cyclophosphamide    Carboplatin    Etoposide    Cisplatin    Etoposide phosphate    Vinblastine    Vinblastine sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   INTERNATIONAL RANDOMIZED STUDY FOR THE SALVAGE TREATMENT OF GERM CELL TUMOURS

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   280
Study Start Date:   February 1994

Detailed Description:

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.

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
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002566

Locations
France
Institut Gustave Roussy    
      Villejuif, France, F-94805

Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer

Investigators
Study Chair:     Jose-Louis Pico, MD     Institut Gustave Roussy    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000063579, FRE-IT94, FRE-FNCLCC-IT94, NCI-F94-0019
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002566
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent malignant testicular germ cell tumor  
extragonadal germ cell tumor  

Study placed in the following topic categories:
Vinblastine
Testicular Neoplasms
Cyclophosphamide
Carboplatin
Etoposide phosphate
Recurrence
Ifosfamide
Cisplatin
Neoplasms, Germ Cell and Embryonal
Testicular cancer
Etoposide
Extragonadal Germ Cell Tumor
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on September 19, 2008




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