Recurrent Ovarian Germ Cell Tumor Clinical Trial
Official title:
Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. 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.
PRIMARY OBJECTIVES:
I. Determine the response rate in pediatric patients with recurrent or resistant malignant
germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the
tumor bank that will aid in the identification of the biological characteristics of recurrent
GCT.
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 count returns 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.
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