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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004262
First received: January 28, 2000
Last updated: June 3, 2013
Last verified: June 2013
  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.


Condition Intervention Phase
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Procedure: conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Radiation: stereotactic radiosurgery
Drug: motexafin gadolinium
Procedure: magnetic resonance imaging
Procedure: spectroscopy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0 [ Time Frame: At the time of stereotactic radiosurgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry [ Time Frame: At baseline, at 48 hours, and at 2 weeks post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 1999
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: conventional surgery
Other Name: surgery, conventional
Radiation: 3-dimensional conformal radiation therapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
Radiation: stereotactic radiosurgery Drug: motexafin gadolinium
Given IV
Other Names:
  • gadolinium texaphyrin
  • Gd (III) Texaphryin
  • Gd-Tex
  • PCI-0120
  • Xcytrin
Procedure: magnetic resonance imaging
Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: spectroscopy
Undergo plasma-atomic emission spectroscopy (DCP-AES)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004262

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Investigators
Principal Investigator: John Grecula Ohio State University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004262     History of Changes
Other Study ID Numbers: NCI-2012-01400, 99H0239, CDR0000067517, NCI-T99-0041, OSU-9976, OSU-99H0239, U01CA076576
Study First Received: January 28, 2000
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 15, 2014