Clinical trial NCT01400958: Nuvigil or Placebo in Newly Diagnosed Malignant Glioma
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignant Glioma
Keywords: fatigue
external beam radiation
EBRT
radiation therapy
placebo
cognitive function
TMZ
Temozolomide
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Cephalon
First posted: 2011-07-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people receiving external beam radiation therapy for the treatment of malignant gliomas. It is also being done to determine if Nuvigil® improves cognitive function (perception, thinking, reasoning, and remembering) and overall quality of life in people receiving external beam radiation therapy for the treatment of malignant gliomas. Another purpose of this study is to see if people who receive Nuvigil® have more or less side effects than people who receive placebo. Placebo is a substance that looks like an active drug but has no active ingredient.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Improved Fatigue Experience After Treatment
timeFrame: 5 months
Secondary outcomes:
measure: Occurrence of Improved Cognitive Performance
timeFrame: 5 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Peter Forsyth, M.D.
role: PRINCIPAL_INVESTIGATOR
References: