Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Motexafin gadolinium

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