Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
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About
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. 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.
Full description
PRIMARY OBJECTIVES:
I. 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.
II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
III. 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
- 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
- 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
- Performance status - Karnofsky 60-100%
- At least 3 months
- Hemoglobin at least 10.0 g/dL
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- SGPT no greater than 60 U/L
- Creatinine no greater than 1.3 mg/dL
- Blood urea nitrogen no greater than 24 mg/dL
- 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
- At least 6 weeks since prior chemotherapy
- Concurrent steroids allowed
- No prior radiotherapy to the brain or upper neck
- No greater than 5 weeks since prior surgery and recovered
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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