A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

NCT00314808 | Completed Phase 1 Results

• 2 other identifiers: Pro000075597136-05-6R0
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms; Nausea; Vomiting

Keywords

primary gliomas; brain tumors; vomiting; appetite suppression; appetite

Outcome Measures

Primary Outcomes (2)

• Tolerability Rate

  Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events

  Two months

• Unacceptable Toxicity Rate

  Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities

  2 months

Secondary Outcomes (3)

• Mean Change From Baseline in Quality of Life -- FACT-Br

  baseline and 2 months

• Mean Change From Baseline in Quality of Life -- FLIE

  baseline, 24 hours, and 72 hours

• Mean Change From Baseline in Quality of Life -- MMSE

  baseline and 2 months

Study Arms (1)

Dronabinol

EXPERIMENTAL

Drug: Dronabinol

Interventions

Dronabinol DRUG

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

Also known as: delta-9-Tetrahydrocannabinol

Dronabinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Nausea; Vomiting

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Deborah H. Allen, MSN, RN, CNS, FNP-BC, AOCNP
• Organization: Duke University

allen079@mc.duke.edu

(919) 681-4719

Study Officials

• Deborah H Allen, MSN, RN, CNS, FNP-BC, AOCNP

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: April 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: July 16, 2014
• Results First Posted: August 6, 2013

Record last verified: 2013-06

Locations

US (1)