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A Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Nuvigil® (Armodafinil) in Newly Diagnosed Malignant Glioma Patients Experiencing Fatigue Secondary to External Beam Radiation Therapy and Concurrent Temozolomide


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Glioma

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Trial Information

A Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Nuvigil® (Armodafinil) in Newly Diagnosed Malignant Glioma Patients Experiencing Fatigue Secondary to External Beam Radiation Therapy and Concurrent Temozolomide


Study visit times will correspond with standard follow-up evaluations for the patient's
malignant glioma.

Study visits will occur at baseline (Week 0); Week 7, which is when patients stop their use
of study drug and their first round of external beam radiation therapy and temozolomide; and
at Weeks 10, 18, and 34.

The Week 7 evaluation will include: neuropsychological exam, Psychosocial Questionnaires,
and questions about the patient's medications and health.

The Week 10 and 18 evaluations will include: vital sign measurements, Karnofsky Performance
status rating, neurological and neuropsychological exams, psychosocial questionnaires, an
Magnetic Resonance Imaging (MRI) of the patient's brain, and questions about their
medications and health.

The Week 34 evaluation will include: vital sign measurements, Karnofsky Performance status
rating, neurological and neuropsychological exams, psychosocial questionnaires, and
questions about the patient's medications and health.


Inclusion Criteria:



- Ages 18 years or greater at study entry

- Histologic diagnosis of a supratentorial World Health Organization (WHO) grade 3
anaplastic glioma (including astrocytoma, oligodendroglioma, and mixed
oligoastrocytoma) or WHO grade 4 glioblastoma which requires external beam radiation
therapy (EBRT) and concurrent temozolomide (TMZ)

- Have adequate renal and liver function as evidenced by the following screening lab
values: Creatinine ≤ 1.7mg/dl; Total Bilirubin ≤ 1.5mg/dl; Transaminases ≤ 4 times
above the upper normal limit; Prothrombin time/international normalized ratio
(PT/INR) < 1.4 for patients not on warfarin

- Adequate bone marrow functions as defined by the following lab values: Absolute
neutrophil count (ANC) ≥ 1,500/mm³; Platelets ≥ 100,000 cells/mm³; Hemoglobin ≥
10.0 gm/dL; White blood cell count (WBC) ≥ 3,000/mcL

- Karnofsky Performance Status ≥ 60%

- Recovered from the immediate neurosurgical post-operative period (e.g. for
craniotomy, at least a 2 week period of time to allow for wound healing)

- Agrees to use acceptable birth control method(s). Females using steroidal
contraception (oral, depot, or implantable) must agree to use an alternative or
concomitant method of contraception throughout therapy as well as for one month after
discontinuation of therapy.

- Agrees to avoid alcohol consumption while on therapy

Exclusion Criteria:

- Pre-existing documented traumatic brain injury

- Pre-existing dementing illness due to degenerative, cerebrovascular, or other static
or progressive neurologic process

- Neurological deficit such as hemineglect or homonymous hemianopsia on baseline
neurologic examination that would preclude effective participation in cognitive
testing

- Intracranial space occupying lesion other than malignant glioma or benign
asymptomatic meningioma

- Prior treatment with EBRT or stereotactic radiosurgery (SRS) to the brain

- Prior treatment with Nuvigil® or Provigil® within 4 weeks prior to study entry

- Leptomeningeal disease suggested clinically or by radiographic criteria

- History of left ventricular cardiac hypertrophy

- Ischemic ECG changes, chest pain, arrhythmia, or other clinically significant
manifestations of mitral valve prolapse in association with central nervous system
(CNS) stimulant use within the past 6 months

- Unstable angina or myocardial infarction within the past 6 months

- Premorbid or ongoing psychosis

- Currently receiving Ritalin or Tricyclic Antidepressants. Nuvigil has been
demonstrated to affect the serum levels of Triazolam and Cyclosporine. Patients
taking these medications will be monitored for potential dose adjustments. Other
medications that are metabolized by the cytochrome P450 pathway may be potentially
affected, but have not been demonstrated to do so in clinical testing. Such
medications will be monitored throughout the study for possible dose adjustments.

- Patients who are experiencing significant fatigue secondary to medical or physiologic
causes other than primarily from their malignant gliomas

- Pregnant, breast-feeding, or lack of willingness to use recommended birth control
methods

- Patients with known hypersensitivity to modafinil, armodafinil, or its inactive
ingredients

- Patients unable to understand or comply with all conditions of the protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Number of Participants With Improved Fatigue Experience

Outcome Description:

Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas.

Outcome Time Frame:

36 weeks per participant

Safety Issue:

No

Principal Investigator

Peter Forsyth, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-16233

NCT ID:

NCT01400958

Start Date:

December 2010

Completion Date:

January 2015

Related Keywords:

  • Malignant Glioma
  • fatigue
  • external beam radiation
  • EBRT
  • radiation therapy
  • placebo
  • cognitive function
  • TMZ
  • Temozolomide
  • Glioma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612