Overview
Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Status:
Completed
Completed
Trial end date:
2003-04-01
2003-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy. PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Motexafin gadolinium
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Grade IVastrocytoma Located supratentorially At least 2 weeks and no more than 4 weeks since prior
surgery for GBM No recurrent disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL AST and ALT
no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2
times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: HIV negative No history of
porphyria No glucose-6-phosphate dehydrogenase deficiency No other malignancy within the
past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
antineoplastic agent for GBM No concurrent chemotherapy during and for 2 weeks after study
No other concurrent antineoplastic investigational agent Endocrine therapy: Prior and
concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy to the brain
Surgery: See Disease Characteristics Other: Concurrent anticonvulsants allowed Other
concurrent cancer therapy allowed if medically necessary