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Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme Clinical research trials and Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme. Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme clinical trial. Human subjects often get the best healthcare available for their Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme  Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme.
Details: OBJECTIVES: - Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery. - Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population. - Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients. OUTLINE: This is a dose escalation study. Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery. Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 3 months, and then every 3 months for 5 years or until death. PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection - Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery AND - Tumor must be at least 1.0 cm from the optic chiasm and brainstem - No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas - No infratentorial tumors - No multifocal glioblastoma multiforme - Tumor enhances on MRI - Must have visible tumor on postoperative MRI following surgical resection PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - Hemoglobin at least 10.0 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGPT no greater than 60 U/L Renal: - Creatinine no greater than 1.3 mg/dL - Blood urea nitrogen no greater than 24 mg/dL Other: - Neurological function status 0-3 - No evidence of neuropathy - No glucose-6-phosphate dehydrogenase deficiency - No known history of porphyria - History of prior malignancies allowed - HIV positive status allowed - No medical contraindication to MRI imaging (i.e., pacemaker, aneurysm clip, or nonsecure metal fragment close to a critical structure) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception prior to and during study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 6 weeks since prior chemotherapy Endocrine therapy: - Concurrent steroids allowed Radiotherapy: - No prior radiotherapy to the brain or upper neck Surgery: - See Disease Characteristics - No greater than 5 weeks since prior surgery and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGrecula, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000067517; OSU-9976,OSU-99H0239,NCI-T99-0041
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004262
Other Adult Glioblastoma Multiforme Studies:
1. Irinotecan in Treating Patients With Recurrent Malignant Glioma
2. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
3. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
4. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme
5. Taurolidine in Treating Patients With Recurrent or Progressive Glioma
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
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Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
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