Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer

University of California, Davis

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Breast Cancer

Interventions

filgrastimBIOLOGICAL

monoclonal antibody m170BIOLOGICAL

cyclosporineDRUG

paclitaxelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of California Davis Cancer Center

Sacramento, California, United States

Data from ClinicalTrials.gov

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