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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT00302159
Eligibility Criteria:
* INCLUSION CRITERIA:
Histological diagnosis:
Pathologically confirmed glioblastoma multiforme.
Histologic diagnosis of glioblastoma multiforme (GBM) will have been established by biopsy or resection no more than 6 weeks prior to enrollment.
The patient is a candidate for definitive external beam radiotherapy.
Patients must be older than 18 years with a life expectancy greater than 8 weeks.
Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Patients must have a primary medical oncologist in the community who is willing to collaborate with the Radiation Oncology Branch (ROB) staff in the clinical management of the patient, specifically in the prescription of Temozolomide and toxicity monitoring in the adjuvant phase.
Laboratory functions:
Adequate bone marrow function defined as a peripheral absolute granulocyte count of greater than 1500/mm\^3, hemoglobin greater than 10gm/dL, and platelet count greater than 100,000/mm\^3.
Adequate liver function, defined as bilirubin and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 2 x the upper limit of normal.
Serum creatinine less than 1.5 mg/dl.
Serum albumin greater than 0.75 x normal.
All patients or their legal guardian must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any of the protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
EXCLUSION CRITERIA
Prior therapy:
Patients who have previously received valproic acid.
Patients who have previously received radiation therapy to the brain.
Patients who have received chemotherapy for the treatment of their high grade glioma or who are currently receiving other investigational chemotherapeutic agents.
Patients with a known history of disorders of urea metabolism.
Concurrent therapy:
The concurrent use of sulfamethoxazole, salicylates or naproxen is not allowed.
Patients with a history of or concurrent second malignancy other than non-melanoma skin cancer or cervical cancer less than 3 years since GBM diagnosis.
Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
Clinically significant unrelated systemic illness which in the judgement of the Principal or Associate Investigator would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results, including but not limited to Insulin dependent diabetes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00302159
Study Brief:
Protocol Section:
NCT00302159