Trial Outcomes & Findings for A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas (NCT NCT00314808)

Last Updated: 2014-07-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

33 participants

Primary outcome timeframe

Two months

Results posted on

2014-07-16

Participant Flow

Patients were accrued between May 2006 and June 2009 within the clinic at Duke Comprehensive Cancer Center.

Participant milestones

Participant milestones
Measure	Dronabinol 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 Study STARTED	33
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Dronabinol 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 Study Disease Progression without AE	4
Overall Study Withdrawal by Subject/PI without AE	4

Baseline Characteristics

A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol n=33 Participants 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
Age, Continuous	46.6 years STANDARD_DEVIATION 12.7 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants

PRIMARY outcome

Timeframe: Two months

Population: 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.

Outcome measures

Outcome measures
Measure	Dronabinol n=25 Participants 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
Tolerability Rate	60 percentage of participants Interval 39.0 to 79.0

PRIMARY outcome

Timeframe: 2 months

Population: All treated patients

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

Outcome measures

Outcome measures
Measure	Dronabinol n=33 Participants 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
Unacceptable Toxicity Rate	0 percentage of participants Interval 0.0 to 11.0

SECONDARY outcome

Timeframe: baseline and 2 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Dronabinol n=19 Participants 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
Mean Change From Baseline in Quality of Life -- FACT-Br Physical Well-Being (N=19)	1.68 units on a scale Standard Deviation 6.75
Mean Change From Baseline in Quality of Life -- FACT-Br Social Well-Being (N=19)	0.47 units on a scale Standard Deviation 3.58
Mean Change From Baseline in Quality of Life -- FACT-Br Emotional Well-Being (N=19)	1.58 units on a scale Standard Deviation 6.1
Mean Change From Baseline in Quality of Life -- FACT-Br Functional Well-Being (N=19)	2.26 units on a scale Standard Deviation 6.33
Mean Change From Baseline in Quality of Life -- FACT-Br Additional Concerns (N=11)	1.77 units on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: baseline, 24 hours, and 72 hours

Population: For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 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.

Outcome measures

Outcome measures
Measure	Dronabinol n=28 Participants 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
Mean Change From Baseline in Quality of Life -- FLIE Nausea at 24 hours	-13.07 units on a scale Standard Deviation 3.50
Mean Change From Baseline in Quality of Life -- FLIE Nausea at 72 hours	-4.18 units on a scale Standard Deviation 3.52
Mean Change From Baseline in Quality of Life -- FLIE Emesis at 24 hours	-10.96 units on a scale Standard Deviation 3.10
Mean Change From Baseline in Quality of Life -- FLIE Emesis at 72 hours	-3.50 units on a scale Standard Deviation 2.82

SECONDARY outcome

Timeframe: baseline and 2 months

Population: 17 patients provided both a pre- and post-treatment assessment of MMSE.

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.

Outcome measures

Outcome measures
Measure	Dronabinol n=17 Participants 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
Mean Change From Baseline in Quality of Life -- MMSE	1.41 units on a scale Standard Deviation 3.47

Adverse Events

Dronabinol

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dronabinol n=33 participants at risk 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
Infections and infestations Wound infection	3.0% 1/33 • 2 months

Other adverse events

Other adverse events
Measure	Dronabinol n=33 participants at risk 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
Gastrointestinal disorders Nausea	36.4% 12/33 • 2 months
Gastrointestinal disorders Vomiting	30.3% 10/33 • 2 months
General disorders Fatigue	12.1% 4/33 • 2 months
Metabolism and nutrition disorders Anorexia	6.1% 2/33 • 2 months
Nervous system disorders Cognitive disturbance	6.1% 2/33 • 2 months
Nervous system disorders Depressed level of consciousness	12.1% 4/33 • 2 months
Nervous system disorders Dysphasia	6.1% 2/33 • 2 months
Nervous system disorders Headache	9.1% 3/33 • 2 months
Nervous system disorders Seizure	6.1% 2/33 • 2 months
Nervous system disorders Tremor	6.1% 2/33 • 2 months
Psychiatric disorders Anxiety	6.1% 2/33 • 2 months
Reproductive system and breast disorders Reproductive system and breast disorders - Other	6.1% 2/33 • 2 months

Additional Information

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

Duke University

Phone: (919) 681-4719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place