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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain Neoplasms
Nausea
Vomiting
Intervention Drug: Dronabinol
Enrollment 33
Recruitment Details Patients were accrued between May 2006 and June 2009 within the clinic at Duke Comprehensive Cancer Center.
Pre-assignment Details  
Arm/Group Title Dronabinol
Hide Arm/Group Description Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Period Title: Overall Study
Started 33
Completed 25 [1]
Not Completed 8
Reason Not Completed
Disease Progression without AE             4
Withdrawal by Subject/PI without AE             4
[1]
Completed 2 cycles of Dronabinol or terminated early due to treatment-related adverse events (AE)
Arm/Group Title Dronabinol
Hide Arm/Group Description Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
46.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
13
  39.4%
Male
20
  60.6%
1.Primary Outcome
Title Tolerability Rate
Hide Description 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
Time Frame Two months
Hide Outcome Measure Data
Hide Analysis Population Description
25 of the 33 patients treated with Dronabinol completed 2 cycles of protocol treatment or terminated protocol treatment due to adverse events. The remaining 8 patients are excluded from this tabulation as they terminated Dronabinol treatment before completion of 2 cycles of treatment for reasons unrelated to adverse events.
Arm/Group Title Dronabinol
Hide Arm/Group Description:
Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60
(39 to 79)
2.Primary Outcome
Title Unacceptable Toxicity Rate
Hide Description 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
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Dronabinol
Hide Arm/Group Description:
Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 11)
3.Secondary Outcome
Title Mean Change From Baseline in Quality of Life -- FACT-Br
Hide Description 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.
Time Frame baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
19 patients provided both baseline and follow-up assessments; however, only 11 patients provided adequate information to compute the score for the additional brain cancer specific concerns subscale.
Arm/Group Title Dronabinol
Hide Arm/Group Description:
Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Well-Being (N=19) 1.68  (6.75)
Social Well-Being (N=19) 0.47  (3.58)
Emotional Well-Being (N=19) 1.58  (6.1)
Functional Well-Being (N=19) 2.26  (6.33)
Additional Concerns (N=11) 1.77  (11.2)
4.Secondary Outcome
Title Mean Change From Baseline in Quality of Life -- FLIE
Hide Description 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.
Time Frame baseline, 24 hours, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 and 72 hours.
Arm/Group Title Dronabinol
Hide Arm/Group Description:
Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Nausea at 24 hours -13.07  (3.50)
Nausea at 72 hours -4.18  (3.52)
Emesis at 24 hours -10.96  (3.10)
Emesis at 72 hours -3.50  (2.82)
5.Secondary Outcome
Title Mean Change From Baseline in Quality of Life -- MMSE
Hide Description 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.
Time Frame baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
17 patients provided both a pre- and post-treatment assessment of MMSE.
Arm/Group Title Dronabinol
Hide Arm/Group Description:
Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.41  (3.47)
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol
Hide Arm/Group Description Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
All-Cause Mortality
Dronabinol
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Dronabinol
Affected / at Risk (%)
Total   1/33 (3.03%) 
Infections and infestations   
Wound infection  1  1/33 (3.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol
Affected / at Risk (%)
Total   12/33 (36.36%) 
Gastrointestinal disorders   
Nausea  1  12/33 (36.36%) 
Vomiting  1  10/33 (30.30%) 
General disorders   
Fatigue  1  4/33 (12.12%) 
Metabolism and nutrition disorders   
Anorexia  1  2/33 (6.06%) 
Nervous system disorders   
Cognitive disturbance  1  2/33 (6.06%) 
Depressed level of consciousness  1  4/33 (12.12%) 
Dysphasia  1  2/33 (6.06%) 
Headache  1  3/33 (9.09%) 
Seizure  1  2/33 (6.06%) 
Tremor  1  2/33 (6.06%) 
Psychiatric disorders   
Anxiety  1  2/33 (6.06%) 
Reproductive system and breast disorders   
Reproductive system and breast disorders - Other  1  2/33 (6.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Deborah H. Allen, MSN, RN, CNS, FNP-BC, AOCNP
Organization: Duke University
Phone: (919) 681-4719
EMail: allen079@mc.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00314808    
Other Study ID Numbers: Pro00007559
7136-05-6R0 ( Other Identifier: Duke legacy protocol number )
First Submitted: April 13, 2006
First Posted: April 17, 2006
Results First Submitted: May 2, 2013
Results First Posted: August 6, 2013
Last Update Posted: July 16, 2014