Ifosfamide |
Ifex |
Clinical Trial: Repeated Bone Marrow Transplantation in Treating Patients With Advanced Breast Cancer
This study is no longer recruiting patients.
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Purpose
RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating patients who have stage IV breast cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage IV breast cancer | Procedure: chemotherapy Procedure: biological response modifier therapy Procedure: radiation therapy Procedure: isotope therapy Procedure: colony-stimulating factor therapy Procedure: peripheral blood stem cell transplantation Procedure: cytokine therapy Drug: bone marrow ablation with stem cell support Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin Drug: filgrastim Drug: fluorouracil Drug: ifosfamide Drug: melphalan Drug: paclitaxel Drug: samarium Sm 153 lexidronam pentasodium Drug: thiotepa | Phase I Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Study of Samarium 153 and Autologous Bone Marrow Transplantation for Stage IV Breast Cancer
Study start: March 1997
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer. II. Determine the response rate, median duration of response, and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support.
PROTOCOL OUTLINE: This is a dose escalation study. Patients are first treated with salvage chemotherapy for no more than 4 cycles. At least a partial remission must be achieved. Peripheral blood stem cells (PBSC) are collected following the administration of filgrastim (granulocyte colony-stimulating factor; G-CSF). After recovery from the prior chemotherapy, high dose chemotherapy begins. Paclitaxel is administered as a 24 hour infusion on day -7. Melphalan IV is administered over 1 hour on days -6 and -5. PBSC are infused on day 0. A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy. Samarium 153 is administered on day -14. Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached (defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients). Cyclophosphamide, thiotepa, and carboplatin are infused over 24 hours on days -7 through -4. PBSC are infused on day 0 followed by G-CSF IV. The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study. Patients are followed until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 21 Years - 65 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically proven metastatic breast cancer
- Adequate peripheral blood stem cells harvested and stored
--Prior/Concurrent Therapy--
- Recovered from toxic effects of prior therapy
- Biologic therapy: Not specified
- Chemotherapy: No prior chemotherapy for metastatic disease; Prior adjuvant chemotherapy allowed
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy for metastatic disease
- Surgery: Not specified
--Patient Characteristics--
- Age: 21-65
- Sex: Female
- Performance status: 0-1
- Life expectancy: Not specified
- Hematopoietic: Not specified
- Hepatic: Bilirubin less than 1.5 mg/dL; SGOT and SGPT normal
- Renal: Creatinine less than 1.5 mg/dL
- Cardiovascular: Ejection fraction of at least 50%; No symptomatic coronary artery disease
- Pulmonary: FEV1 and DLCO greater than 50% of predicted
- Other: Not pregnant; Not HIV positive; Not hepatitis B surface antigen positive; No uncontrolled infection; No other prior malignancy within 5 years except: Curatively treated in situ adenocarcinoma of the cervix; Curatively treated nonmelanoma skin cancer
Location Information
Louisiana
Louisiana State University School of Medicine, Shreveport, Louisiana, 71130-3932, United States
Benjamin Barry Weinberger, Study Chair, Louisiana State University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003086
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Ifex (Drug Digest)
- Ifosfamide (Drug Digest)

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