Breast Cancer Clinical Trial
Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for metastatic breast cancer.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy, cyclosporine, and paclitaxel in treating patients who have recurrent or refractory metastatic breast cancer.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody m170 in combination with cyclosporine and paclitaxel in patients with recurrent or refractory metastatic breast cancer.
Determine the preliminary efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody m170 (Y90 MOAB m170).
Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days prior to apheresis which continues daily for a maximum of 5 days. A minimum of 6 million CD34+ cells/kg must be harvested.
Patients receive oral cyclosporine every 12 hours on days -3 to 25. Patients receive unlabeled monoclonal antibody (MOAB) m170 IV followed by a tracer dose of indium In 111 MOAB m170 IV on day 0. On day 7, patients receive unlabeled MOAB m170 IV followed by Y90 MOAB m170 IV. Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9.
If needed, patients undergo autologous peripheral blood stem cell transplantation on day 21 and receive G-CSF SC daily until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB m170 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 36 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic breast adenocarcinoma
Residual or recurrent disease after first-line standard chemotherapy
Clinical evidence of metastatic disease
Tumor cells positive for m170 immunoreactivity
HAMA titer negative
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
18 and over
Sex:
Not specified
Menopausal status:
Not specified
Performance status:
Karnofsky 70-100%
Life expectancy:
Not specified
Hematopoietic:
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
Renal:
Creatinine less than 1.5 mg/dL
Cardiovascular:
LVEF at least 50% by MUGA
Pulmonary:
FEV1 at least 65% of predicted
FVC at least 65% of predicted
DLCO at least 60%
Other:
No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Chemotherapy
Chemotherapy:
See Disease Characteristics
At least 1 prior chemotherapy regimen for advanced disease
Prior high-dose chemotherapy with autologous stem cell transplantation is allowed if given at least 12 months prior to study and carmustine was not used
At least 4 weeks since prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
At least 4 weeks since prior external beam radiotherapy
No prior radiotherapy to more than 25% of the total skeleton
Surgery:
Not specified
Other:
No requirement for oral anticoagulants (low-dose warfarin for central line thrombosis prophylaxis allowed)
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There is 1 Location for this study
Sacramento California, 95817, United States
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