Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain

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

Summary

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

PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial grade IV astrocytoma

• Glioblastoma multiforme

• Previously untreated disease

• Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• SGOT/SGPT no greater than 4 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 4 times ULN

• PT/APTT normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No uncontrolled hypertension

Other:

• Mini mental state exam score at least 15

• No history of glucose-6-phosphate dehydrogenase deficiency or porphyria

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast

• No serious infection

• No other medical illness that would preclude study participation

• No allergy to MRI contrast (e.g., motexafin gadolinium)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for up to 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy or immunotherapy for this disease, including any of the following:

• Immunotoxins

• Immunoconjugates

• Antisense therapy

• Peptide receptor antagonists

• Interferons

• Interleukins

• Tumor-infiltrating lymphocytes

• Lymphokine-activated killer cell therapy

• Gene therapy

Chemotherapy:

• No prior chemotherapy for this disease

Endocrine therapy:

• Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to treatment on this protocol)

• No other prior hormonal therapy for this disease

Radiotherapy:

• No prior radiotherapy for this disease

Surgery:

• See Disease Characteristics

• Recovered from prior surgery

Other:

• No other concurrent investigational agents