NCT00936936

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Study Drugs: Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die. Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die. Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs. Study Drug Administration: You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart. You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. Starting on the first day of your hospital stay, you will begin gargling and swishing Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and throat sores. On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4 hours and docetaxel over 2 hours. On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15 minutes, and carboplatin over 2 hours. On Day 6, you will not receive any study drugs. On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes. As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 5 days after the transplant, until your blood cell levels return to normal. As part of standard mouth care you will be asked to do mouthwashes 4 times a day with caphosol (artificial saliva) and glutamine. Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second cycle of high-dose chemotherapy. On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6 hours, etoposide over 2 hours, and carboplatin over 2 hours. On Days 5-6, you will not receive any study drugs. On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes. Study Visits: About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the following tests and procedures will be performed: * To check the status of the disease, you will have CT scans of your chest, abdomen, and pelvis. * Blood (about 3 tablespoons) will be drawn for routine tests. Length of Study: You will be off study after about 1 year from your second transplant. You will be taken off study early if the disease gets worse or if you experience any intolerable side effects. Long-Term Follow-up: If your doctor thinks it is needed, you may have follow-up visits.

Conditions

• Testicular Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-02
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2009-07-10
• Last updated: 2024-08-26
• Results posted: 2024-08-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study