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

• Status: Completed
• Trial end date: 2004-03-16
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have supratentorial glioblastoma multiforme that has not been previously treated.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Motexafin gadolinium

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated, supratentorial grade IV glioblastoma multiforme Measurable and contrast enhancing disease on postoperative MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal (ULN) SGOT or SGPT no greater than 4 times ULN PT and aPTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No serious infection or medical illness No history of glucose-6-phosphate dehydrogenase deficiency No known porphyria No other prior malignancy within the past 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for glioblastoma multiforme No prior immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes, lymphokine activated killer cells, or gene therapy for glioblastoma multiforme Chemotherapy: No prior chemotherapy for glioblastoma multiforme Endocrine therapy: No prior hormonal therapy for glioblastoma multiforme Stable corticosteroid regimen for at least 5 days prior to study Radiotherapy: No prior radiotherapy for glioblastoma multiforme Surgery: Recovered from postoperative complications Other: No other concurrent investigational agents