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Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer Clinical research trials and Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer clinical trial. Participants frequently get the best healthcare available for their Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer  Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): University of California Davis Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolRichman, Study Chair, University of California Davis Cancer Center
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Additional Information:
Study ID Numbers: CDR0000068369; NCI-V00-1640,UCD-992080
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009763
Other Stage 4 Breast Cancer Studies:
1. BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
2. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
3. ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
4. Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
5. Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
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