High-dose Chemotherapy for Poor-prognosis Relapsed Germ-Cell Tumors
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.
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. One (1) week before your admission to the hospital for the first cycle (about 2 weeks
before the stem cell transplant), you will receive bevacizumab through the CVC over 90
minutes.
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. One (1) week before your admission to the hospital for this
second cycle (about 2 weeks before the stem cell transplant), you will receive bevacizumab
through the CVC over 90 minutes.
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.
This is an investigational study. Bevacizumab is FDA approved and commercially available
for the treatment of colorectal cancer and breast cancer. Gemcitabine, docetaxel, melphalan,
ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for
the treatment of germ-cell tumors. The use of bevacizumab with gemcitabine, docetaxel,
melphalan, and carboplatin, and with ifosfamide, carboplatin and etoposide is
investigational.
Up to 40 patients will take part in this multicenter study. Up to 40 will be enrolled at MD
Anderson.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2-year Event-Free Survival (EFS)
2 Years
No
Yago Nieto, MD, PHD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2008-0378
NCT00936936
June 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |
Fred Hutchinson Cancer Center | Seattle, Washington 98109 |