Clinical Trial: Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: INTENSIVE CHEMOTHERAPY FOR RELAPSED OR REFRACTORY GERM CELL TUMORS EMPLOYING HIGH-DOSE CARBOPLATIN, ETOPOSIDE, AND THIOTEPA WITH AUTOLOGOUS BONE MARROW RESCUE FOR PATIENTS 15 TO 60 YEARS OF AGE

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer.

Detailed Summary:

OBJECTIVES: I. Determine the response rate, overall survival, and disease-free survival of patients with refractory or relapsed germ cell carcinoma treated with high-dose induction chemotherapy comprising carboplatin and etoposide followed by autologous bone marrow or peripheral blood stem cell rescue.

OUTLINE: Autologous peripheral blood stem cells (PBSC) or bone marrow is harvested. Patients receive carboplatin IV continuously and etoposide IV over 1 hour on days -5 through -3. Autologous PBSC or bone marrow is reinfused on day 0.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Sponsor: Temple University

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Temple University

Dates:
Date Received: November 1, 1999
Date Started: November 1990
Date Completion:
Last Updated: September 30, 2010
Last Verified: September 2010