A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas - Full Text View

Sponsor:	Duke University
Collaborator:	Solvay Pharmaceuticals
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00314808

Purpose

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.

Condition	Intervention	Phase
Brain Neoplasms Nausea Vomiting	Drug: Dronabinol	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Nausea and Vomiting

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Tolerability Rate and absence of toxicity [ Time Frame: Two cycles of chemotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of Life measurements [ Time Frame: Two cycles of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314808

Contacts

Contact: Deborah H Allen, MSN, ARN, BC	919-681-4719	allen079@mc.duke.edu
Contact: Waynette Freeman, RN	919-684-3440	Freem050@mc.duke.edu

Locations

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

Sponsors and Collaborators

Duke University

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Deborah H Allen, MSN, ARN, BC

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center/Preston Robert Tisch Brain Tumor Center ( Deborah H Allen, MSN,RN,CNS,FNP-BC,AOCNP )
Study ID Numbers:	7136-05-6R0/00007559
Study First Received:	April 13, 2006
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00314808 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

primary gliomas
brain tumors
vomiting
appetite suppression
appetite

Additional relevant MeSH terms:

Vomiting
Signs and Symptoms, Digestive
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Psychotropic Drugs
Hallucinogens
Central Nervous System Neoplasms
Brain Diseases
Signs and Symptoms
Neoplasms by Site
Sensory System Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Analgesics
Glioma

Nervous System Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Tetrahydrocannabinol
Neuroectodermal Tumors
Brain Neoplasms
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Neoplasms, Neuroepithelial
Central Nervous System Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009