Low Dose Naltrexone for Glioma Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Malignant Glioma

In brief

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

Key facts

Study ID

NCT01303835

Run by

Katy Peters

People needed

110

Starts

2011-05-01

Expected to finish

2015-05-01

Last updated by the study team

2015-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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