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

Study Purpose

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.

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 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

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.

 NCT00032097
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.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 James L. Pearlman, MD
Principal Investigator Affiliation H. Lee Moffitt Cancer Center and Research Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 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:

  • - 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.

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.

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231

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