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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers Clinical research trials and Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers clinical trial. Subjects frequently get the best healthcare possible for their Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers  Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
For Condition: Brain Tumor
Status: Completed
Sponsor(s): Duke Comprehensive Cancer Center ,
Synopsis: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.
Details: OBJECTIVES: I. Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas. II. Determine the objective therapeutic response of these patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs no). Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly. Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven primary or metastatic malignant supratentorial anaplastic glioma - Newly diagnosed or recurrent - No diffusely infiltrating or multifocal tumor - No tumor with subependymal spread Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study Measurable lesion on enhanced CT or MRI - No measurable enhancing lesion greater than 1.0 cm beyond cavity margin Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progression Endocrine therapy: Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry Radiotherapy: At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Surgery: See Disease Characteristics --Patient Characteristics-- Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: - Absolute neutrophil count greater than 1,000/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Bilirubin less than 1.5 mg/dL - AST less than 1.5 times normal - Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception
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: CDR0000064688; DUMC-2426-01-2R8,NCI-H96-0009,DUMC-000223-00-2R7,DUMC-0328-99-2R6,DUMC-221-96-2R3,DUMC-307-97-2R4,DUMC-307-98-2R5
Study Start Date: February 1993
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002752
Other Brain Tumor Studies:
1. Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
2. Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
3. P-glycoprotein Antagonist, Tariquidar, in Combination with Doxorubicin (Adriamycin), Vinorelbine (Navelbine), or Docetaxel to Treat Children with Solid Tumors
4. Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor
5. Phenylbutyrate to Treat Children with Progressive or Recurrent Brain Tumors
Related Studies:
Other Brain Tumor Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
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