- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003899
Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
High-Dose Consolidation With Escalating Doses of Melphalan and Thiotepa for Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or 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 plus bone marrow or peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.
Study Overview
Status
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of melphalan and thiopeta in patients with recurrent or refractory solid tumors. II. Evaluate the overall survival and response rate in these patients.
OUTLINE: This is a dose escalation study. Patients receive cyclophosphamide IV over 1 hour on day 1 and paclitaxel IV over 4 or 24 hours on day 2, followed by daily filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing through day 7 or until WBCs are greater than 100,000 cells/mm3. Peripheral blood stem cells (PBSC) or autologous bone marrow is collected on days 5-7. At 30-50 days following mobilization, patients receive melphalan IV over 15-60 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2, followed by autologous bone marrow transplantation or PBSC infusion on day 0. Sequential dose escalation of melphalan is followed by sequential dose escalation of thiotepa. Dose escalation in cohorts of 5 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4, 3 of 7, 4 of 11, or 5 of 15 patients experience dose limiting toxicity. Patients are followed at 60 days and at 12 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor Metastatic disease Recurrent or refractory Pleural effusions allowed, if controlled Brain metastases allowed, if symptoms controlled and negative MRI
PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No uncontrolled bleeding Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and/or SGPT less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Normal EKG Ejection fraction at least 45% Patients with abnormal EKG, history of myocardial infarction, unstable angina, congestive heart failure, or prior cumulative anthracycline dose of at least 250 mg/m2, must have a left ventricular ejection fraction performed No congestive heart failure or uncontrolled hypertension Pulmonary: DLCO greater than 60% No pneumonia No asthma, even if controlled Neurologic: No dementia or altered mental status Other: No active infection (e.g., peritonitis, wound abscess) HIV negative No prior cyclophosphamide induced hemorrhagic cystitis No serious concurrent systemic disease (e.g., diabetes mellitus, hypothyroidism) No other active malignancies Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy allowed Radiotherapy: No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: William I. Bensinger, MD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Cyclophosphamide
- Paclitaxel
- Melphalan
- Thiotepa
Other Study ID Numbers
- 1343.00
- FHCRC-1343.00
- NCI-H99-0032
- CDR000006707 (Registry Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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