Malignant GliomaPhase 2NCT01400958
Nuvigil or Placebo in Newly Diagnosed Malignant Glioma
A Phase 2 study testing Nuvigil® in people with Malignant Glioma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Nuvigil®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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
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.
Read the 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.
- Conditions
- Malignant Glioma
- Being tested
- Nuvigil®, Placebo
- Keywords
- fatigue, external beam radiation, EBRT, radiation therapy, placebo, cognitive function, TMZ, Temozolomide
- Medical subject headings
- Glioma, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuvigil®Drug
Also called Armodafinil
Nuvigil® 150 mg/day x 42 days THEN, No More Drug
PlaceboDrug
Placebo x 42 days; THEN, No More Placebo
| Study group | Role | What they receive |
|---|---|---|
| A: Nuvigil® | Active comparator | 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). Receives: Drug: Nuvigil® |
| B: Placebo | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Improved Fatigue Experience After Treatment
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).
Measured: 5 months
Secondary outcomes (1)
Occurrence of Improved Cognitive Performance
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionSep 2013
Why it stopped: Slow Accrual, Initiating Principal Investigator (PI) left Moffitt
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Peter Forsyth, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400958
- Sponsor's protocol ID
- MCC-16233
- Other IDs
- C10953/6253
- Status last verified
- Oct 2013
- First submitted
- 21 Jul 2011
- Last updated
- 16 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01400958
- Acronym / sponsor ID
- MCC-16233
- Conditions
- Malignant Glioma
- Keywords
- fatigue, external beam radiation, EBRT, radiation therapy, placebo, cognitive function, TMZ, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual, Initiating Principal Investigator (PI) left Moffitt
- Enrolment
- 6 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 16 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Nuvigil® | Active comparator | Drug: 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). |
| B: Placebo | Placebo comparator | Drug: PlaceboStudy 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvigil®Also: ArmodafinilNuvigil® 150 mg/day x 42 days THEN, No More Drug | Drug | A: Nuvigil® |
| PlaceboPlacebo x 42 days; THEN, No More Placebo | Drug | B: Placebo |
Primary outcome
Occurrence of Improved Fatigue Experience After Treatment
Time frame: 5 months
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).
1 secondary outcome
Occurrence of Improved Cognitive Performance
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Forsyth, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nuvigil® in people with Malignant Glioma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Improved Fatigue Experience After Treatment (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.