NCT00002508

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Extragonadal Germ Cell Tumor
• Ovarian Cancer
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	etoposide
PROCEDURE	autologous bone marrow transplantation
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 1990-11-01
• Primary completion: 2001-09-01
• Completion: 2001-09-01
• First posted: 2004-03-11
• Last updated: 2010-10-01

Locations

1 site across 1 country: United States