Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
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 I trial to study the effectiveness of melphalan and thiotepa followed by peripheral stem cell transplantation in treating patients with stage III or stage IV epithelial ovarian cancer in complete remission.
|Ovarian Cancer||Biological: filgrastim Drug: melphalan Drug: thiotepa Procedure: peripheral blood stem cell transplantation||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of Melphalan and Thiotepa Followed by Autologous or Syngeneic Peripheral Blood Stem Cell (PBSC) Rescue in Patients With a Complete Response Following Standard Therapy for Stage III/IV Epithelial Ovarian Cancer|
|Study Start Date:||January 1997|
|Primary Completion Date:||November 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the toxic effects of combined high dose melphalan and thiotepa chemotherapy followed by stem cell rescue in patients with stage III or IV ovarian epithelial cancer in complete remission. II. Determine the maximum tolerated dose of thiotepa that can be given with melphalan in these patients. III. Evaluate the interpatient blood level variability and pharmacokinetics of melphalan given intravenously.
OUTLINE: This is a dose escalation study of thiotepa. Patients receive cytoreduction and mobilization of peripheral blood stem cells (PBSC) with filgrastim (G-CSF) and cyclophosphamide/paclitaxel, cyclophosphamide/etoposide or cyclophosphamide/etoposide/cisplatin within 30-90 days of last dose of standard therapy. PBSC are then collected. Patients then receive melphalan IV over 30 minutes on days -6 and -5 and thiotepa IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. G-CSF is administered on days 0-21. Cohorts of 5-15 patients each receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is reached. The MTD is determined as the dose at which 2-5 of 4-15 patients experience dose limiting toxicity. Patients are followed at 100 days, then at 6, 12, and 24 months.
PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study over 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002977
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Leona A. Holmberg, MD, PhD||Fred Hutchinson Cancer Research Center|