A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Condition(s) targeted: Brain Neoplasms; Nausea; Vomiting

Intervention: Dronabinol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Deborah H Allen, MSN, ARN, BC, Principal Investigator, Affiliation: Duke University

Overall contact:
Deborah H Allen, MSN, ARN, BC, Phone: 919-681-4719, Email: allen079@mc.duke.edu

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.

Official title: A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Tolerability Rate and absence of toxicity

Secondary outcome: Quality of Life measurements

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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; CCNU or CPT-11

- Patients must give written informed consent

- Patients must have AST, 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 CMS diagnosis (CVA, CHI, 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

Deborah H Allen, MSN, ARN, BC, Phone: 919-681-4719, Email: allen079@mc.duke.edu

Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Deborah H Allen, MSN, ARN, BC, Phone: 919-681-4719, Email: allen079@mc.duke.edu
Waynette Freeman, RN, Phone: 919-684-3440, Email: Freem050@mc.duke.edu
Deborah H Allen, MSN, ARN, BC, Principal Investigator

Starting date: April 2006
Ending date: December 2009
Last updated: December 26, 2008