Clinical trial NCT00314808: A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
Official title: A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Neoplasms
Nausea
Vomiting
Keywords: primary gliomas
brain tumors
vomiting
appetite suppression
appetite
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-04-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 Fields, 1998). There has been little information published on the impact of these symptoms in the glioblastoma multiforme (GBM) population. More specifically, to date, there has not been an investigation that demonstrates the efficacy of an intervention on improving appetite, and decreasing nausea and vomiting in patients with GBM. This need serves as the basis for the current proposed investigation utilizing Dronabinol, a cannabinoid known to decrease incidence of nausea and vomiting, as well as controlling appetite changes for terminally ill patients receiving chemotherapy. In addition, there is no published research on the use of Dronabinol and dose limited toxicity for the brain tumor population.

In this study, patients will receive daily Dronabinol therapy through their chemotherapy cycle. Patients will complete daily appetite and nausea/vomiting logs, as well as receive telephone follow-up from the research coordinator to assess impact of treatment. This will be assessed through two consecutive cycles of chemotherapy.

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

Primary outcomes:
measure: Tolerability Rate
timeFrame: Two months
measure: Unacceptable Toxicity Rate
timeFrame: 2 months
Secondary outcomes:
measure: Mean Change From Baseline in Quality of Life -- FACT-Br
timeFrame: baseline and 2 months
measure: Mean Change From Baseline in Quality of Life -- FLIE
timeFrame: baseline, 24 hours, and 72 hours
measure: Mean Change From Baseline in Quality of Life -- MMSE
timeFrame: baseline and 2 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Preston Robert Tisch Brain Tumor Center at Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Deborah H Allen, MSN, RN, CNS, FNP-BC, AOCNP
role: PRINCIPAL_INVESTIGATOR
References: