Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT00486603
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed grade IV supratentorial astrocytoma (glioblastoma multiforme)
* Newly diagnosed disease
* Diagnosis must have been made by biopsy or resection ≤ 3 months prior to study entry
INCLUSION CRITERIA:
* Patients must be at least 18 years of age.
* Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme), established by biopsy or resection not more than 3 months prior to registration.
* Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor. Glucocorticoid therapy is allowed.
* Patients must have a Karnofsky performance status ≤ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
* Patients must have the following hematologic, renal and liver function (i.e. absolute neutrophil count \> 1500/mm3, platelets \> 100,000/mm3, creatinine ≤ 2 times the upper limits of normal (ULN) total bilirubin ≤ 1.5 mg/dl, ALT and AST ≤ 4 times above the upper limits of the institutional norm.
* Patients must be able to provide written informed consent.
* Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant.
* Patients must have a Mini Mental State Exam (MMSE) score of \> 15.
* Patients must have tumor tissue form completed and signed by a pathologist. See section 9.5.2 for details.
* Prior concurrent therapy:
* No prior radiotherapy, chemotherapy, immunotherapy, biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy), or hormonal therapy for brain tumor
* No prior polifeprosan 20 with carmustine implant (Gliadel wafer) or GliaSite® brachytherapy
* No concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
* No other concurrent chemotherapeutic or investigational agents for this cancer
* Concurrent glucocorticoids allowed
EXCLUSION CRITERIA:
* Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
* Patients who are pregnant or breast-feeding.
* Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents).
* Patients with a concurrent or prior malignancy, unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for five years are eligible for this study.
* Patients who have received Gliadel wafers or GliaSite brachytherapy are not eligible.
* Due to risk of disease exacerbation patients with porphyria are not eligible.
* Due to risk of disease exacerbation patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
* Patients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (EIADs) (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine).
* Patients with previously documented macular degeneration or diabetic retinopathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00486603
Study Brief:
Protocol Section:
NCT00486603