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Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme

Study Purpose

Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.

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

Inclusion Criteria:

  • - Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection.
  • - Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery.
  • - Tumor must be at least 1.0 cm from the optic chiasm and brainstem.
  • - No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas.
  • - No infratentorial tumors.
  • - No multifocal glioblastoma multiforme.
  • - Tumor enhances on MRI.
  • - Must have visible tumor on postoperative MRI following surgical resection.
  • - Performance status - Karnofsky 60-100% - At least 3 months.
  • - Hemoglobin at least 10.0 g/dL.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
  • - Bilirubin no greater than 1.5 mg/dL.
  • - SGPT no greater than 60 U/L.
  • - Creatinine no greater than 1.3 mg/dL.
  • - Blood urea nitrogen no greater than 24 mg/dL.
  • - Neurological function status 0-3.
  • - No evidence of neuropathy.
  • - No glucose-6-phosphate dehydrogenase deficiency.
  • - No known history of porphyria.
  • - History of prior malignancies allowed.
  • - HIV positive status allowed.
  • - No medical contraindication to MRI imaging (i.e., pacemaker, aneurysm clip, or nonsecure metal fragment close to a critical structure) - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception prior to and during study.
  • - At least 6 weeks since prior chemotherapy.
  • - Concurrent steroids allowed.
  • - No prior radiotherapy to the brain or upper neck.
- No greater than 5 weeks since prior surgery and recovered

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.

 NCT00004262
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.

 John Grecula
Principal Investigator Affiliation Ohio State University
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.

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
Additional Details

PRIMARY OBJECTIVES:

  • I. Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery.
  • II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
  • III. Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients.
OUTLINE: This is a dose escalation study. Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery. Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 3 months, and then every 3 months for 5 years or until death. PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.

Arms & Interventions

Arms

Experimental: Treatment (motexafin gadolinium, radiotherapy, radiosurgery)

Within 5 weeks following surgery, patients receive daily external beam radiotherapy five days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery.

Interventions

Procedure: - conventional surgery

Radiation: - 3-dimensional conformal radiation therapy

Radiation: - stereotactic radiosurgery

Drug: - motexafin gadolinium

Given IV

Procedure: - magnetic resonance imaging

Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets

Procedure: - spectroscopy

Undergo plasma-atomic emission spectroscopy (DCP-AES)

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.

Columbus, Ohio

Status

Address

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210

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