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High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

NCT00936936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-26

Study results available
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Summary

The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.

This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.

Up to 67 patients will be enrolled in this study.

Conditions

  • Testicular Cancer

Interventions

DRUG

Gemcitabine

1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.

DRUG

Docetaxel

Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.

DRUG

Melphalan

50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.

DRUG

Carboplatin

Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.

DRUG

Mesna

3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.

DRUG

Ifosfamide

3,000 mg/m\^2 IV over 6 hours on Days -6 to -3

DRUG

Etoposide

200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.

PROCEDURE

Stem Cell Transplant

Stem cell infusion on Day 0.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yago Nieto, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-02
Primary Completion
2024-01-11
Completion
2024-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936936 on ClinicalTrials.gov