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Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
This study is ongoing, but not recruiting participants.
Study NCT00002977   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
January 1997
 
 
 
Complete list of historical versions of study NCT00002977 on ClinicalTrials.gov Archive Site
 
 
 
Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
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

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.

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.

Phase I
Interventional
Treatment
Ovarian Cancer
  • Biological: filgrastim
  • Drug: melphalan
  • Drug: thiotepa
  • Procedure: peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
45
 
 

DISEASE CHARACTERISTICS: Histologically confirmed stage III/IV ovarian epithelial cancer in first or second clinical complete remission after receiving a minimum of 4-10 courses of chemotherapy consisting of paclitaxel and either cisplatin or carboplatin Ovarian epithelial cancer of following histologic types: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell Adenocarcinoma N.O.S. Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner's Tumor Remission stability maintained for at least 4 weeks Protocol therapy must begin 30-90 days after last dose of standard therapy No active pleural or pericardial effusion No prior/concurrent brain metastasis or carcinoid meningitis

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 times the upper limit of normal (ULN) SGOT or SGPT less than 2.0 times ULN Albumin greater than 2.0 g/dL Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction greater than 45% by MUGA Pulmonary: If history of smoking or abnormal lung function, Diffusion capacity greater than 50% (corrected) A-a gradient less than 20 Other: No history of hemorrhagic cystitis No second malignancy within the last 5 years except basal cell skin cancer HIV negative No chronic active hepatitis B No hepatitis C No history of Aspergillus infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplant Chemotherapy: Prior chemotherapy consisting of paclitaxel and either cisplatin or carboplatin Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for malignancy (excluding chest wall radiation therapy for breast cancer) Surgery: Not specified

Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002977
 
CDR0000065499, FHCRC-1181.00, NCI-G97-1229
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP