Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
- Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens
with autologous stem cell rescue in patients with relapsed germ cell cancer.
- Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem
cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support
in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem
cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells
cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel
IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and
carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a
second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours,
then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV
is given twice a day until 3 consecutive postnadir days of granulocytes of at least
1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sumanta Pal, MD
City of Hope Medical Center
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|