Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
This trial is active, not recruiting.
|Treatments||filgrastim, monoclonal antibody m170, cyclosporine, paclitaxel, peripheral blood stem cell transplantation, yttrium y 90 monoclonal antibody m170|
|Sponsor||University of California, Davis|
|Start date||March 2001|
|Trial identifier||NCT00009763, CDR0000068369, NCI-V00-1640, UCD-992080|
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.
Male or female participants at least 18 years old.
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)
|Official title||Combined Modality Radioimmunotherapy For Metastatic Breast Adenocarcinoma With Two Cycles Of Escalating Dose 90Y-DOTA-peptide-m170 and Fixed, Low Dose Paclitaxel With Blood Stem Cell Support And Cyclosporin For HAMA Suppression|
|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.|
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