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Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer Clinical research trials and Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer. Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer  Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer
Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer
For Condition: Breast Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will test the safety and effectiveness of a radioactive antibody called Y-90-B3 in treating advanced breast cancer. Antibodies are substances made by the body's immune system to defend against things foreign to the body. The B3 antibody attaches to cells-including cancer cells-that have the B3 antigen (protein). For this study, the Antibody B3 is tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The radioactive antibody-Y-90-B3-is designed to bind (attach) to and destroy the tumor cells with the B3 antigen. (This drug is designed to work only for patients whose tumor cells have the B3 antigen.) The radiation from the high doses of Y-90-B3 treatment suppresses bone marrow function, however, causing very low blood cells counts with serious side effects. To lessen these harmful effects, patients will have an autologous stem cell transplantation; that is, infusion of their own previously collected stem cells-primitive cells produced by the bone marrow that make red and white blood cells and platelets. Patients 18 years of age and older with stage IV breast cancer may be eligible for this study. Participants must live within a 100-mile radius of Bethesda, Maryland, or be willing to stay in the area for observation for at least 8 weeks after Y-90-B3 treatment. Candidates will be screened for eligibility with a history and physical examination, blood tests, chest X-ray, computed tomography (CT) scans and tests to evaluate heart and lung function. The patient's cancer cells will also be examined for the presence of B3 antigen. This will either require a biopsy (removal of a small sample of tumor tissue under local anesthetic) or examination of previously biopsied tissue. Patients enrolled in the study will first undergo apheresis to collect stem cells. For this procedure, an intravenous (IV) line (a thin, flexible catheter) is placed in a vein in both the right and left arms. Blood is drawn from one of the arm veins and flows through a machine that separates it into its components. The stem cells are removed and the rest of the blood is returned to the body through the other arm vein. Beginning 5 days before the apheresis, the patient receives injections under the skin of a drug called G-CSF, a growth factor that increases the amount of stem cells in the blood, optimizing the number that can be collected for transplantation. After sufficient stem cells are collected, patients will be injected with a dose of B3 antibody tagged with a radioactive material called Indium-111. Body scans will be done daily for 1 to 7 days to see if the antibody binds to the tumor. If B3 binds to the tumor, then a dose of the experimental drug, Y-90-B3, will be injected 4 days to 2 weeks later. The dose will vary for different groups of patients. Seven to 15 days after Y-90-B3 treatment, the patient's stem cells will be infused. One week after the infusion, patients will begin to self-administer injections of G-CSF, and will continue daily injections for at least 3 weeks. The injections are given under the skin, similar to self-administered insulin injections for diabetes. Before starting treatment, patients will have an IV called a central venous catheter, or "Hickman catheter," inserted. It is placed in the upper part of the chest and tunneled under the skin into a neck vein. This catheter is used to give the antibody injections, red blood cell or platelet transfusions, the stem cell transfusions, and medications such as antibiotics and fluids. It will also be used to draw blood samples. Depending on their response to the treatment, patients may be hospitalized for 3 to 6 weeks or longer. They will then be followed as an outpatient at the NIH Clinical Center first once a month and then every other month.
Details: This is a Phase I study of (90)Y-B3 with autologous stem cell support for patients with metastatic breast carcinoma. The primary objectives of this study are to determine the dose-limiting toxicities and the maximum tolerated dose of (90)Y-B3 when administered with stem cell support. B3 is a murine monoclonal antibody directed against a carbohydrate antigen of the Le(y) family that is present on the surface of many human carcinomas. Seventy percent of breast carcinomas express the B3 antigen. Secondary objectives are to evaluate the anti-tumor activity and the immunogenicity of this agent when given in marrow ablative doses.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Eligible patients are limited to stage IV breast cancer patients with histologically or cytologically proven evaluable or measurable disease. Pathology must be reviewed by the Department of Pathology of the NCI. At least one site of relapse or metastatic disease must have been confirmed by pathologic or cytologic material. Patients must have progressive disease after at least one chemotherapy regimen for metastatic disease, with or without prior adjuvant chemotherapy. Patients must have received an anthracycline and a taxane as part of the chemotherapy regimens for either adjuvant or metastatic disease. The patients tumor tissue must express B3 antigen on the surface of greater than 30 % of the tumor cells. Patients must be 18 years old and be able to give informed consent. ECOG performance status of 0 or 1. Chemistry and CBC parameters: serum creatinine 1.4 mg/dl, SGOT and SGPT 2 times of the upper limits of normal; total bilirubin, within normal limits; prothrombin time, within normal limits; AGC greater than 2, 000 per mm(3); platelets greater than 100,000 per mm(3). Patients must have ejection fraction by MUGA scan or Echocardiogram of 45%. Patients must have Pulmonary Function Test showing FEV1 greater than 60% of predicted, FVC and DLCO greater than or equal to 55% to be eligible. Patients must have recovered from the toxic effects of prior chemotherapy or radiation therapy. Specifically, this should be grade 1 hematologic toxicity with the exception of hemoglobin, and grade 1 toxicity (CTC v2.0) for all other systems 4 weeks after the completion of last therapy. There will be no limitation for eligibility based on an abnormal hemoglobin measurement. At least 4 weeks must have lapsed since last dose of chemotherapy or hormonal therapy (at least 6 weeks must have elapsed since the last dose of Mitomycin C and a nitrosourea). At least 4 weeks must have lapsed since last dose of radiation therapy. Patients must live within 100 miles from the Clinical Center or be willing to remain within the area for at least 8 weeks after radioimmunotherapy. EXCLUSION CRITERIA: Patients who have received high dose chemotherapy with bone marrow transplant therapy or stem cell infusion are excluded. Patients who have received radiation therapy to pelvis and/or spine are excluded. Local radiation therapy to one site (excluding pelvis/spine) will be permitted provided that at least 4 weeks have lapsed and the patient meets all other entry criteria. Patients with CNS metastasis and/or known seizure disorders are excluded. Patients with an active second malignancy (except treated basal cell skin carcinoma) are excluded. Patients who require anticoagulants or chronic steroids therapy are excluded. Patients with any coexisting medial or psychiatric condition that is likely to interfere with study procedures and/or results are excluded. Patients with a history of auto-immune diseases are excluded. Due to deleterious effects of radiation to fetus and children, patients known or found to be pregnant and patients who are breast feeding are excluded from this study. Patients of childbearing potential must agree to use an effective method of contraception. Due to the potential immunosuppressive effect of radio-immunotherapy, patients with positive HIV are excluded from this study. Patients with positive hepatitis B antigen, hepatitis C are excluded due to the potential of liver toxicity by (90)Y-B3. Patients with known prior exposure to mouse antibody are excluded.
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000206; 00-C-0206
Study Start Date: August 24, 2000
Record last reviewed: November 6, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006197
Other Breast Cancer Studies:
1. Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
2. Study of Etoposide in Breast Cancer Patients
3. Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
4. Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
5. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
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Radiolabeled Antibody with Stem Cell Transfusion to Treat Advanced Breast Cancer
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