Status:
COMPLETED
A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
Lead Sponsor:
Duke University
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Brain Neoplasms
Nausea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study seeks to define the tolerability and safety associated with the administration of Dronabinol in the treatment of adults with nausea, vomiting and appetite loss in patients with primary glio...
Detailed Description
Symptoms identified as impacting quality of life include nausea and vomiting, appetite changes, pain, fatigue, mobility, insomnia, mood, bowel patterns, concentration and appearance (Donaldson and Fie...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed diagnosis of primary malignant brain tumor (grade 3 or 4)
- Karnofsky greater than or equal to 80%
- Life expectancy greater than or equal to 6 months
- Patients must be undergoing one of the following chemotherapy administrations: Temozolomide; Lomustine (CCNU) or Irinotecan or Camptosar (CPT-11)
- Patients must give written informed consent
- Patients must have aspartate aminotransferase (AST), alanine transaminase (ALT), total serum bilirubin, and alkaline phosphatase less than 2 times upper limits of normal laboratory values, performed within 14 days prior to initiation of study
- For women, negative risk of pregnancy through standard chemotherapy screening procedures inclusive of pregnancy test, menopause or surgical procedure
- Patient must have social support with caregiver daily monitoring for side effects
Exclusion
- Premorbid central nervous system (CNS) diagnosis (cerebral vascular accident (CVA), closed head injury (CHI), multiple sclerosis (MS)
- Patients with global aphesis limiting the informed consent process
- Patients with unmanaged psychiatric disease
- Patients with history of drug addiction or recent illicit drug usage within the last 3 months
- Patients with hypersensitivity to dronabinol, marijuana or sesame seed oil
- Patients must not be taking an concomitant meds contraindicated with Dronabinol (including anxiolytics, sedative, hypnotics, barbiturates, general anesthetics, monoamine oxidase inhibitors \[MAOIs\], opiate agonists, phenothiazines, sedating H1 blockers, skeletal muscle relaxants and sympathomimetics)
- Patients who have hepatic enzyme elevation of greater than two times upper limits of normal laboratory values for AST, ALT, total serum bilirubin or alkaline phosphatase
- Pregnant or breastfeeding women
- Women of childbearing potential who are not using an effective method of contraception (oral contraceptives, female and/or male barrier devices, spermicidal agents, or surgical procedures inhibiting contraception)
- Patients who live alone
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00314808
Start Date
April 1 2006
End Date
April 1 2012
Last Update
July 16 2014
Active Locations (1)
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1
Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
Durham, North Carolina, United States, 27710