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Phase 3
16 Years
Open (Enrolling)
Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

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Trial Information


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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jose-Louis Pico, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




Start Date:

February 1994

Completion Date:

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • recurrent malignant testicular germ cell tumor
  • extragonadal germ cell tumor
  • Neoplasms, Germ Cell and Embryonal