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Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

Information source: H. Lee Moffitt Cancer Center and Research Institute
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Glioma

Intervention: Nuvigil® (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

Official(s) and/or principal investigator(s):
Edward Pan, M.D., Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

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.

Clinical Details

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

Primary outcome: Number of Participants With Improved Fatigue Experience

Secondary outcome: Number of Participants With Improved Cognitive Performance

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

Locations and Contacts

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States; Recruiting
Pam Smith, Phone: 813-745-3951, Email: pam.smith@moffitt.org
Edward Pan, M.D., Principal Investigator
Margaret Booth-Jones, Sub-Investigator
Additional Information

Moffitt Cancer Center Clinical Trials website

Starting date: December 2010
Last updated: December 6, 2011

Page last updated: December 08, 2011

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