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Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
This study has been completed.
Study NCT00004262   Information provided by National Cancer Institute (NCI)
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes

January 28, 2000
February 6, 2009
November 1999
 
 
 
Complete list of historical versions of study NCT00004262 on ClinicalTrials.gov Archive Site
 
 
 
Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
Phase I Trial of Gadolinium Texaphyrin (PCI-0120) as a Radiosensitizer During Stereotactic Radiosurgery Boost for Gliobalstoma Multiforme

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme.

OBJECTIVES:

  • 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.
  • Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5 and 8 Tesla MRI images in this patient population.
  • 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.

Phase I
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: motexafin gadolinium
  • Procedure: conventional surgery
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
 
Christoforidis GA, Grecula JC, Newton HB, Kangarlu A, Abduljalil AM, Schmalbrock P, Chakeres DW. Visualization of microvascularity in glioblastoma multiforme with 8-T high-spatial-resolution MR imaging. AJNR Am J Neuroradiol. 2002 Oct;23(9):1553-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • 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 AND
  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin at least 10.0 g/dL
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGPT no greater than 60 U/L

Renal:

  • Creatinine no greater than 1.3 mg/dL
  • Blood urea nitrogen no greater than 24 mg/dL

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 6 weeks since prior chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • No prior radiotherapy to the brain or upper neck

Surgery:

  • See Disease Characteristics
  • No greater than 5 weeks since prior surgery and recovered
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004262
 
CDR0000067517, OSU-9976, OSU-99H0239, NCI-T99-0041
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Study Chair: John C. Grecula, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
March 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP