A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
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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 |
|---|---|
|
Brain Neoplasms Nausea Vomiting |
Drug: Dronabinol |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas |
- Tolerability Rate and absence of toxicity [ Time Frame: Two cycles of chemotherapy ] [ Designated as safety issue: Yes ]
- Quality of Life measurements [ Time Frame: Two cycles of chemotherapy ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | April 2006 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dronabinol |
Drug: Dronabinol
Oral route, 5mg PO 2x daily before and during 2 cycles of chemotherapy,2.5mg PO every night when not on chemotherapy
Other Name: delta-9-Tetrahydrocannabinol
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Preston Robert Tisch Brain Tumor Center at Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Deborah H Allen, MSN, ARN, BC | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00314808 History of Changes |
| Other Study ID Numbers: | Pro00007559/7136-05-6R0 |
| Study First Received: | April 13, 2006 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
primary gliomas brain tumors vomiting appetite suppression appetite |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Glioma Nausea Vomiting Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Signs and Symptoms, Digestive Signs and Symptoms Tetrahydrocannabinol Hallucinogens Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013