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
试验速览
- 阶段
- 1 期
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •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
- •Bilirubin no greater than 1.5 mg/dL
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular:
- •LVEF at least 50% by MUGA
- •FEV1 at least 65% of predicted
- •FVC at least 65% of predicted
- •DLCO at least 60%
- •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
- •Not specified
- •No requirement for oral anticoagulants (low-dose warfarin for central line thrombosis prophylaxis allowed)
排除标准
- 未提供