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Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors Clinical research trials and Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors. Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors  Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
For Condition: Brain Tumor,Central Nervous System Tumor
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.
Details: OBJECTIVES: I. Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy. II. Determine objective therapeutic responses of these patients to this treatment. PROTOCOL OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6). Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical resection of the tumor or brain metastasis, at which time an indwelling intracranial resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter. Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. After the MTD has been established, patients in the phase II portion of the study receive therapy as in phase I. Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy. Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression. Patients are followed initially at 4 weeks, then every 6 weeks for 1 year. PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor - No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors - Candidate for surgical resection - Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required - Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6 --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count greater than 1000/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin less than 1.5 mg/dL - Alkaline phosphatase less than 1.5 times normal - Lactic dehydrogenase less than 1.5 times normal - SGOT less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No iodine allergies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DarellBigner, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066522; DUMC-1533-01-8R4,NCI-5P0NS20023,NCI-G98-1472,DUMC-1373-97-9,DUMC-1408-98-9R1,DUMC-1533-00-8R3,DUMC-1570-99-9R2,DUMC-97107
Study Start Date: September 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003484
Other Brain Tumor Studies:
1. Natural History of Patients with Brain and Spinal Cord Tumors
2. Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
Related Studies:
Other Brain Tumor Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
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