Adult Glioblastoma Clinical Trial
Official title:
PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | May 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At the time of stereotactic radiosurgery | Yes | |
Secondary | Concentration of gadolinium in tumor, normal brain, and plasma by plasma-atomic emission spectroscopy and liquid chromatography with mass spectrometry | At baseline, at 48 hours, and at 2 weeks post-surgery | No |
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