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Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation. PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme requiring radical radiotherapy No anaplastic astrocytoma or low-grade astrocytoma Able to start radiotherapy within 5 weeks of definitive surgery (unless delay due to cause other than medical illness or poor performance status) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and ALT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 mg/dL PT and aPTT no greater than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe lung disease Other: No other significant life-threatening disease No other active malignancy No known glucose-6-phosphate dehydrogenase deficiency No known porphyria Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception.PRIOR CONCURRENT THERAPY: Biologic therapy: No biologic therapy for at least 4 weeks after study completion No immunotherapy for at least 4 weeks after study completion Chemotherapy: No chemotherapy for at least 4 weeks after study completion Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics No prior radiotherapy for this disease or other brain tumor No prior radiotherapy to face, head, or neck Surgery: See Disease Characteristics Recovered from prior surgery or postoperative complication Other: At least 48 hours since prior MRI scan with contrast No concurrent MRI scans with contrast No other concurrent experimental drug

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00003409
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jonsson Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Judith M. Ford, MD, PhD
Principal Investigator Affiliation	Jonsson Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain and Central Nervous System Tumors

Additional Details

OBJECTIVES:

I. Determine the safety and tolerability of motexafin gadolinium in combination with radiotherapy in patients with newly diagnosed glioblastoma multiforme.

II. Determine the intratumoral pharmacology and quantitative pharmacokinetics of this drug in this patient population.

OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium. Patients receive a loading dose regimen comprising motexafin gadolinium IV over 10-15 minutes on days 1-5 or days 1-5 and 8-12 (cohort 7). After the loading dose regimen, patients receive a maintenance regimen comprising motexafin gadolinium IV 3 times weekly for a maximum of 6.5 weeks. Patients also undergo radiotherapy once daily, 5 days a week, for 6.5 weeks. Cohorts of 3-6 patients receive an escalating number of doses of motexafin gadolinium 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 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781

Sacramento, California