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
21 Years
65 Years
Female
Breast Cancer
Trial Information
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
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 -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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Benjamin B. Weinberger, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Authority:
United States: Federal Government
Study ID:
CDR0000065786
NCT ID:
NCT00003086
Start Date:
March 1997
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
