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| Sponsored by: |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003086 |
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 women who have stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: filgrastim Drug: CAF regimen Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: ifosfamide Drug: melphalan Drug: paclitaxel Drug: thiotepa Procedure: peripheral blood stem cell transplantation Radiation: samarium Sm 153 lexidronam pentasodium |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Study of Samarium 153 as Part of a Double (Sequential) Autologous Bone Marrow Transplant (ABMT) for Patients With Stage IV Breast Cancer |
| Estimated Enrollment: | 12 |
| Study Start Date: | 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.
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
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer Adequate peripheral blood stem cells harvested and stored
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
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
Contacts and Locations| United States, Louisiana | |
| Louisiana State University School of Medicine | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| Study Chair: | Benjamin B. Weinberger, MD | Feist-Weiller Cancer Center at Louisiana State University Health Sciences |
More Information
| Study ID Numbers: | CDR0000065786, LSU-97447, NCI-V97-1341 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003086 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer |
|
Antimetabolites Melphalan Immunologic Factors Cyclophosphamide Anti-Bacterial Agents Cisplatin Analgesics Alkylating Agents Breast Diseases Skin Diseases Breast Neoplasms Antimitotic Agents Carboplatin Immunosuppressive Agents |
Doxorubicin Thiotepa Ifosfamide Paclitaxel Analgesics, Non-Narcotic Samarium ethylenediaminetetramethylenephosphonate Fluorouracil Tubulin Modulators Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Isophosphamide mustard |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Alkylating Agents Breast Diseases Skin Diseases |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Ifosfamide Neoplasms Analgesics, Non-Narcotic Paclitaxel Samarium ethylenediaminetetramethylenephosphonate Fluorouracil Tubulin Modulators Myeloablative Agonists |
