Clinical Trial Details
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NCT01303835 : Low-Dose Naltrexone for Glioma Patients
PhasePhase 2
AgesMin: 18 Years Max: N/A
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, ANC ? 1,500 cells/microliter, platelets ? 100,000

- 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

- 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
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