Ovarian Cancer Clinical Trial
Official title:
A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
Chemoprotective drugs such as amifostine may protect normal cells from the side effects of
high-dose chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side
effects of peripheral stem cell transplantation in treating patients who have high-risk or
relapsed solid tumors.
OBJECTIVES:
- Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood
stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid
tumors or brain tumors.
- Determine response or time to disease progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to
age (1 to 18 vs 19 to 45 years).
All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration,
patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy.
Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over
30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients receive
amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa
administration on days -5 to -1. PBSC are reinfused on day 0.
Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated
dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC
transplantation.
PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study
within 3 years.
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