Status:
TERMINATED
Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system ...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Metastatic disease
- Meets 1 of the following criteria:
- Chemotherapy-unresponsive disease defined as 1 of the following:
- Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession
- Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen
- Histologically confirmed tumor involvement on bone marrow biopsy
- Measurable or evaluable disease\* defined as the following:
- Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI
- Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only)
- Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: \*Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease
- Appropriate candidate for allogeneic stem cell transplantation
- No active CNS metastases
- Available HLA-identical sibling donor
- 6/6 antigen match
- Donor CD34 cells at least 2 times 10\^6/kg recipient weight
- Hormone receptor status:
- Estrogen receptor negative or positive
- Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation
- PATIENT CHARACTERISTICS:
- Age
- 18 to 60
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- Karnofsky 70-100% OR
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC at least 1,500/mm\^3
- Platelet count at least 30,000/mm\^3
- Hepatic
- Bilirubin less than 3 times normal\*
- AST and ALT less than 3 times normal\* NOTE: \*Unless abnormality due to malignancy
- Renal
- Creatinine no greater than 1.6 mg/dL
- Cardiovascular
- LVEF greater than 40% by echocardiography or MUGA
- No myocardial infarction within the past 6 months
- Pulmonary
- DLCO greater than 40% of predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No serious localized or systemic infection
- No hypersensitivity to E. coli-derived products
- No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix
- No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication
- No psychological condition or social situation that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- No concurrent glucocorticoids
- Radiotherapy
- No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy
- Surgery
- Not specified
- Other
- No concurrent immunosuppressive medication
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00074269
Start Date
July 1 2003
End Date
March 1 2008
Last Update
June 5 2023
Active Locations (1)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658