Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil; Temozolomide

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