A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dronabinol

About this trial

This is an interventional treatment trial for Brain Neoplasms focused on measuring primary gliomas, brain tumors, vomiting, appetite suppression, appetite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dronabinol

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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.

Full Information

NCT ID

NCT00314808

First Posted

April 13, 2006

Last Updated

July 10, 2014

Sponsor

Duke University

Collaborators

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00314808

Brief Title

A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Official Title

A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Neoplasms, Nausea, Vomiting

Keywords

primary gliomas, brain tumors, vomiting, appetite suppression, appetite

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dronabinol

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dronabinol

Other Intervention Name(s)

delta-9-Tetrahydrocannabinol

Intervention Description

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

Primary Outcome Measure Information:

Title

Tolerability Rate

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

Title

Unacceptable Toxicity Rate

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

Secondary Outcome Measure Information:

Title

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

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

Title

Mean Change From Baseline in Quality of Life -- FLIE

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

Title

Mean Change From Baseline in Quality of Life -- MMSE

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Brain Neoplasms, Nausea, Vomiting

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial