Expired Study
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Sacramento, California 95817


Purpose:

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.


Study summary:

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.


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)


NCT ID:

NCT00009763


Primary Contact:

Study Chair
Carol M. Richman, MD
University of California, Davis


Backup Contact:

N/A


Location Contact:

Sacramento, California 95817
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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