A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
Condition: Brain Neoplasms; Nausea; Vomiting
MeSH terms: Glioma; Brain Neoplasms; Vomiting
Intervention: Dronabinol
Intervention description: Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy
Intervention MeSH terms: Dronabinol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: primary gliomas; brain tumors; vomiting; appetite suppression; appetite

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 gliomas who are undergoing chemotherapy treatment. The study will also describe
      the effect of Dronabinol on the quality of life in terms of nausea, vomiting and anorexia in
      this patient group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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