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

NCT ID: NCT00004262

Last Updated: 2013-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30

Brief Summary

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.

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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

conventional surgery

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

stereotactic radiosurgery

Intervention Type: RADIATION

motexafin gadolinium

Intervention Type: DRUG

Given IV

magnetic resonance imaging

Intervention Type: PROCEDURE

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

spectroscopy

Intervention Type: PROCEDURE

Undergo plasma-atomic emission spectroscopy (DCP-AES)

Interventions

conventional surgery

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

stereotactic radiosurgery

Intervention Type: RADIATION

motexafin gadolinium

Given IV

Intervention Type: DRUG

magnetic resonance imaging

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

Intervention Type: PROCEDURE

spectroscopy

Undergo plasma-atomic emission spectroscopy (DCP-AES)

Intervention Type: PROCEDURE

Other Intervention Names

surgery, conventional; 3D conformal radiation therapy; 3D-CRT; gadolinium texaphyrin; Gd (III) Texaphryin; Gd-Tex; PCI-0120; Xcytrin; MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Grecula

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Columbus, Ohio, United States

Countries

United States

Other Identifiers

99H0239

Identifier Type: -

Identifier Source: secondary_id

CDR0000067517

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0041

Identifier Type: -

Identifier Source: secondary_id

OSU-9976

Identifier Type: -

Identifier Source: secondary_id

OSU-99H0239

Identifier Type: -

Identifier Source: secondary_id

U01CA076576

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01400

Identifier Type: -

Identifier Source: org_study_id