PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
18 Years
N/A
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
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 Center | Columbus, Ohio 43210-1240 |
