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

Phase 1CompletedNCT00032097

National Cancer Institute (NCI)

Overview

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.

OBJECTIVES: * Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy. * Determine the maximum tolerated doses of this drug on these 2 schedules in these patients. * Determine the pharmacokinetic profile of this drug in these patients. * Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients. * Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients. * Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients are sequentially assigned to 1 of 2 treatment groups. * Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks. * Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy. Patients undergo cranial radiotherapy as in group I. Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

motexafin gadoliniumDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

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