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A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas


N/A
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms, Nausea, Vomiting

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Trial Information

A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability Rate and absence of toxicity

Outcome Time Frame:

Two cycles of chemotherapy

Safety Issue:

Yes

Principal Investigator

Deborah H Allen, MSN, ARN, BC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00007559/7136-05-6R0

NCT ID:

NCT00314808

Start Date:

April 2006

Completion Date:

April 2012

Related Keywords:

  • Brain Neoplasms
  • Nausea
  • Vomiting
  • primary gliomas
  • brain tumors
  • vomiting
  • appetite suppression
  • appetite
  • Brain Neoplasms
  • Neoplasms
  • Glioma
  • Nausea
  • Vomiting

Name

Location
Preston Robert Tisch Brain Tumor Center at Duke University Medical Center Durham, North Carolina  27710