drugset / Trial / NCT00432094

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

NCT00432094

Phase 2 Completed 23 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival. PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.

Timeline

Start
2006-12-19
Primary completion
2021-03
Completion
2021-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 500 mg/m2 Intravenous
Subject Etoposide Small molecule 600 mg/m2 Intravenous
Subject Ifosfamide Small molecule 2500 mg/m2 Intravenous
Subject Paclitaxel Small molecule 225 mg/m2 Intravenous
Subject Thiotepa Other / unclassified 150 mg/m2 Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 2500 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous