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A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

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ClinicalTrials.gov Identifier: NCT00314808
Recruitment Status : Completed
First Posted : April 17, 2006
Results First Posted : August 6, 2013
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE April 13, 2006
First Posted Date  ICMJE April 17, 2006
Results First Submitted Date  ICMJE May 2, 2013
Results First Posted Date  ICMJE August 6, 2013
Last Update Posted Date July 16, 2014
Study Start Date  ICMJE April 2006
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • Tolerability Rate [ Time Frame: Two months ]
    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
  • Unacceptable Toxicity Rate [ Time Frame: 2 months ]
    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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • Mean Change From Baseline in Quality of Life -- FACT-Br [ Time Frame: baseline and 2 months ]
    The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76.
  • Mean Change From Baseline in Quality of Life -- FLIE [ Time Frame: baseline, 24 hours, and 72 hours ]
    The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54.
  • Mean Change From Baseline in Quality of Life -- MMSE [ Time Frame: baseline and 2 months ]
    The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
Official Title  ICMJE A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Neoplasms
  • Nausea
  • Vomiting
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Dronabinol
Intervention: Drug: Dronabinol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2013)
33
Original Enrollment  ICMJE
 (submitted: April 14, 2006)
34
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314808
Other Study ID Numbers  ICMJE Pro00007559
7136-05-6R0 ( Other Identifier: Duke legacy protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Deborah H Allen, MSN, RN, CNS, FNP-BC, AOCNP Duke University
PRS Account Duke University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP