Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||September 16, 2010|
|Start Date ICMJE||January 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003899 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors|
|Official Title ICMJE||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.
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 ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Unspecified Adult Solid Tumor, Protocol Specific|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003899|
|Other Study ID Numbers ICMJE||1343.00, FHCRC-1343.00, NCI-H99-0032, CDR000006707|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Fred Hutchinson Cancer Research Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||Fred Hutchinson Cancer Research Center|
|Verification Date||September 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP