Ovarian Cancer Clinical Trial
Official title:
High-Dose Thiotepa With Autologous Stem Cell Rescue in Patients With Malignancies Refractory to Conventional Chemotherapy
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.
PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral
stem cell transplantation in treating patients with refractory solid tumors.
OBJECTIVES:
- Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem
cell rescue and filgrastim in patients with malignancies refractory to conventional
chemotherapy or for whom conventional therapy is not available.
- Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis
following high dose thiotepa.
OUTLINE: Patients are stratified by type of tumor (neuroectodermal CNS tumor vs
non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS
tumor).
Autologous stem cells are obtained prior to the administration of thiotepa. Patients who do
not have peripheral blood stem cells available may undergo a bone marrow harvest instead.
Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days. Stem cells are
reinfused approximately 72 hours following the completion of thiotepa. Filgrastim is
administered the day following reinfusion of stem cells and continues until there is
sufficient hematopoietic recovery.
The second course of thiotepa is administered 4 weeks following the first course in patients
who have responding or stable disease, adequate stem cells, and no unacceptable toxicity.
Patients receive a maximum of 2 courses.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 2 years.
;
Primary Purpose: Treatment
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