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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002977 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Biological: filgrastim Drug: melphalan Drug: thiotepa Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | January 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000065499, FHCRC-1181.00, NCI-G97-1229 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002977 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma |
ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma Brenner tumor |
|
Melphalan Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Immunosuppressive Agents |
Pharmacologic Actions Adnexal Diseases Thiotepa Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents Endocrine Gland Neoplasms |
