Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

This study has been terminated.
(Slow Accrual, Initiating Principal Investigator (PI) left Moffitt)
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01400958
First received: July 21, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Malignant Glioma
Drug: Nuvigil®
Drug: Placebo
Phase 2

Study Type: 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
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

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Occurrence of Improved Fatigue Experience After Treatment [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).


Secondary Outcome Measures:
  • Occurrence of Improved Cognitive Performance [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function.


Enrollment: 6
Study Start Date: December 2010
Study Completion Date: September 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: Nuvigil®
Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Drug: Nuvigil®
Nuvigil® 150 mg/day x 42 days THEN, No More Drug
Other Name: Armodafinil
Placebo Comparator: B: Placebo
Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Drug: Placebo
Placebo x 42 days; THEN, No More Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400958

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Cephalon
Investigators
Principal Investigator: Peter Forsyth, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01400958     History of Changes
Other Study ID Numbers: MCC-16233, C10953/6253
Study First Received: July 21, 2011
Results First Received: August 6, 2013
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
fatigue
external beam radiation
EBRT
radiation therapy
placebo
cognitive function
TMZ
Temozolomide

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Armodafinil
Modafinil
Temozolomide
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014