Low Dose Naltrexone for Glioma Patients

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high grade glioma patients undergoing standard chemoradiation

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Katy Peters
• Treatments: Naltrexone

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