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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors Clinical research trials and Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors  Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
For Condition: adult brain tumor
Status: Recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances such as radioactive iodine to them without harming normal cells. PURPOSE: Randomizedphase I/II trial to compare two methods of delivering radiolabeled monoclonal antibody therapy to patients with primary brain tumors.
Details: OBJECTIVES: - Determine which one of two delivery techniques (bolus injection versus microinfusion) provides the greater distribution volume of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) administered intratumorally in patients with newly diagnosed or recurrent malignant primary brain tumors. - Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in these patients. - Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients. OUTLINE: This is a randomized, dose-escalation study. Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) by one of two delivery techniques first, then crossover to receive the antibody by the other technique 3 days later. Each patient then receives a therapeutic dose by the most efficient method. Both methods are delivered via a stereotactically-placed intralesional catheter. - Arm I: Bolus injection method - Arm II: Microinfusion delivery method Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6, with dose escalation occurring separately for each arm. After 10 patients are enrolled and the best method of administration is determined, all subsequent patients receive I 131 MAb 81C6 by that method, and the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more the 2 of 6 patients experience dose-limiting toxicity. Patients with newly diagnosed tumors for which no effective conventional therapy exists, such as malignant glial tumors, are treated with external beam radiotherapy within 4 months after I 131 MAb 81C6 infusion. Patients with recurrent tumors receive no other therapy unless tumor progresses. Patients are followed at 4, 8, 16, and 24 weeks and then every 12 weeks for one year. PROJECTED ACCRUAL: At least 10 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven newly diagnosed or recurrent primary intracranial WHO grade III or IV glioma - Reactivity of tumor cells with 81C6 demonstrated by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody - Radiographic evidence of a single lesion by MRI or CT scan - No greater than 2 to 5 cm - No cerebral herniation syndrome - Midline brain shift less than 0.5 cm PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 10 g/dL Hepatic: - Bilirubin less than 1.5 mg/dL - Alkaline phosphatase less than 1.5 times normal - SGOT less than 1.5 times normal Renal: - Creatinine less than 2.0 mg/dL Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No allergies to iodine or local anesthetics PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent autologous bone marrow transplant Chemotherapy: - No more than 1 prior conventional or phase II chemotherapy regimen - No prior phase I chemotherapy regimens - At least 4 weeks since prior chemotherapy - No concurrent systemic chemotherapy Endocrine therapy: - Corticosteroids allowed but must be on stable dose for at least 1 week Radiotherapy: - At least 3 months since radiotherapy to site of measurable disease in the nervous system, unless evidence of progression Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DarellBigner, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting John Sampson 919-684-3377
Additional Information:
Study ID Numbers: CDR0000066515; DUMC-1529-01-8R4,DUMC-1363-97-9,DUMC-1409-98-9R1,DUMC-1529-00-8R3,DUMC-1630-99-9R2,DUMC-97112,NCI-5950NS20023,NCI-G98-1471
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003478
Other Adult Brain Tumor Studies:
1. Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
2. Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
3. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
4. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
5. Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
Related Studies:
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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
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