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PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME


Phase 1
18 Years
N/A
Not Enrolling
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

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Trial Information

PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

At the time of stereotactic radiosurgery

Safety Issue:

Yes

Principal Investigator

John Grecula

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01400

NCT ID:

NCT00004262

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Glioblastoma
  • Gliosarcoma

Name

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240