Pro00027661 Low-Dose Naltrexone

Clinical Trials for Adults  | Effects of Low-Dose Naltrexone on Quality of Life in High-Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial

Purpose of this study
To compare the effects of low-dose naltrexone versus placebo on quality of life, functional capacity and neurocognition in newly diagnosed high-grade glioma patients undergoing standard chemoradiation

Eligibility, Inclusion

  • Histologically proven high-grade glioma
  • Planned treatment with concurrent radiotherapy and daily oral Temozolomide (Avastin OK)
  • ≥ 18 years of age
  • Karnofsky performance index ≥ 70%
  • No documented cardiac or pulmonary disease
  • No contraindications to six-minute walk test
  • Primary neuro-oncologist approval
  • Hematocrit ≥ 29%, hemoglobin ≥ 9, ANC ≥ 1,500 cells/l, platelets ≥ 100,000 cells/l,
  • Serum creatinine < 1.5 times upper limit of normal, serum 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.

 Exclusion Criteria

  • Prior therapy with naltrexone or naloxone
  • Co-medication that may interfere with study results; e.g. opioids (hydrocodone, morphine, oxycodone, methadone, or codeine while on study)
  • Known hypersensitivity to any component of naltrexone
  • Pregnant (positive pregnancy test within 48 hours of starting chemoradiation) or lactating

 Study Design: Key Features

  • Patients will be randomly assigned to either 4.5mg Naltrexone or placebo
  • 72 patients will be treated on this protocol
  • Naltrexone and placebo are provided free by the study
  • Drug will be taken every night at bedtime for 16 weeks starting the first day of chemoradiation
  • Study lasts 24 weeks
  • All visits linked to regularly scheduled clinic visits
  • Blood work -weekly for 24 weeks
  • Assessments will be done 4 times over the course of the study (at baseline, after chemoradiation, 2 and 4 months after chemo) via a computerized program, and paper surveys along with a six minute walk test

Expected Toxicities

  • Less likely-vivid dreams
  • Rare- nausea, vomiting, loss of appetite, headache, dizziness, anxiety, nervousness, fatigue, trouble sleeping, drowsiness, abdominal pain, bone/joint pain, muscle aches, nasal symptoms






This article comes from The Preston Robert Tisch Brain Tumor Center at Duke   http://www.cancer.duke.edu/btc
The URL for this story is:   http://www.cancer.duke.edu/btc/modules/ClinicalTrials4/index.php?id=105