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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01303835
Eligibility Criteria:
Inclusion Criteria:
* written informed consent prior to beginning specific protocol procedures
* histologically proven high-grade glioma
* planned treatment with concurrent radiotherapy and daily oral temozolomide (with or without Avastin)
* ≥ 18 years of age
* Karnofsky performance index ≥ 70%
* must be able to ambulate unassisted for 6 minutes safely
* The Preston Robert Tisch Brain Tumor Center (PRT-BTC) neuro-oncologist's approval
* hematocrit ≥ 29%, hemoglobin ≥ 9, absolute neutrophil count (ANC) ≥ 1,500 cells/microliter, platelets ≥ 100,000 cells/microliter
* serum creatinine \< 1.5 times upper limit of normal, serum glutamic oxaloacetic transaminase (SGOT) \< 2.5 times upper limit of normal and bilirubin \< 2.0 times upper limit of normal
* if sexually active, patients will take contraceptive measures for the duration of the treatments
* Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of study drug
Exclusion Criteria:
* prior therapy with naltrexone or naloxone
* co-medication that may interfere with study results, e.g. opioids,
* known hypersensitivity to any component of naltrexone
* pregnant (positive pregnancy test) or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01303835
Study Brief:
Protocol Section:
NCT01303835