Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors.
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin|
- Response as measured by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
- Determine the response rate in pediatric patients with recurrent or resistant malignant germ cell tumors treated with paclitaxel, ifosfamide, and carboplatin.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood counts return to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Show 90 Study Locations
|Study Chair:||Carlos Rodriguez-Galindo, MD||Dana-Farber Cancer Institute|
|Investigator:||A. Lindsay Frazier, MD, ScM||Dana-Farber Cancer Institute|