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Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer Clinical research trials and Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer. Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer  Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Garden State Cancer Center
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy used to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have stage IV breast cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of yttrium Y 90 anti-CEA monoclonal antibody MN-14 (hMN-14 antibody) plus peripheral blood stem cell rescue in patients with stage IV breast cancer. II. Determine the pharmacokinetic profile of hMN-14 antibody in the blood, normal organs, and tumors of this patient population. III. Determine the antibody response to hMN-14 in these patients. IV. Determine the antitumor effect of this regimen in these patients. V. Determine the radiation absorbed dose to normal organs and tumors. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients receive filgrastim (G-CSF) subcutaneously (SQ) with or without chemotherapy on days -28 to -14 and peripheral blood stem cell (PBSC) collection on days -14 to -11. If an adequate number of CD34+ cells are not harvested, bone marrow may be collected. Patients receive pretherapy imaging with indium In 111 monoclonal antibody MN-14 (In111-MN-14) IV on day -7 for up to 40 minutes followed by whole body imaging on days -7 to 0. Patients receive yttrium Y 90 anti-CEA monoclonal antibody MN-14 (90Y-hMN-14) IV for up to 40 minutes day 0. PBSC or bone marrow is reinfused on days 6 to 14, depending on antibody clearance. Patients receive G-CSF SQ or IV until blood counts recover. Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are followed weekly for 2 months, monthly for 6 months, and then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven stage IV breast cancer - Measurable disease following firstline chemotherapy - Evidence of CEA expression by: Serum CEA at least 10 ng/mL OR Positive immunostaining of primary or metastatic tumors with a CEA specific antibody - No brain metastases - Bone marrow biopsy prior to stem cell mobilization required to assess cellularity and tumor involvement; Cellularity greater than 60% of normal; Tumor involvement less than 25%; Chromosome analysis of bone marrow aspirate (optional) - No brain metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior peripheral blood stem cell rescue - Chemotherapy: At least 1 course of prior chemotherapy; At least 4 weeks since prior chemotherapy; No prior high dose chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy; No prior radiotherapy to greater than 30% of red bone marrow - Surgery: At least 4 weeks since major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100%; ECOG 0-2 - Menopausal status: Not specified - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 2 mg/dL; AST less than 2 times upper limit of normal - Renal: Creatinine less than 1.5 times ULN - Cardiovascular: Cardiac ejection fraction greater than 50% by MUGA - Pulmonary: DLCO greater than 70% of predicted; FVC and FEV1 greater than 70% of predicted - Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No severe anorexia, nausea or vomiting, or urinary incontinence; No other significant concurrent medical problem including severe psychiatric, epileptic, or diabetic disease; No prisoners; If received prior chimeric or humanized antibody (e.g., Herceptin), must not have allergy to 90 Y humanized MN-14
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackBurton, Study Chair, Garden State Cancer Center
Garden State Cancer Center
Belleville, New Jersey, 07103
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Additional Information:
Study ID Numbers: CDR0000067297; CMMI-C-041A-98,NCI-H99-0039,NCI-V99-1568
Study Start Date: May 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004085
Other Recurrent Breast Cancer Studies:
1. Chemotherapy in Treating Women With Metastatic Breast Cancer
2. CP-724,714 in Treating Patients With Metastatic Breast Cancer
3. Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
4. Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
5. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
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