Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01781468 : Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Age ? 18 years

- Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma,
glioblastoma with oligo features, glioblastoma with primitive neuroectodermal
tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic
oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have
completed radiation therapy > 21 days and ? 24 months prior to enrollment. NOTE:
Clinical stability will be defined as a stable or improved Karnofsky Performance
Status (KPS) compared to the prior month.

- ? 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory)

- Undergone surgery (gross total or subtotal resection) or biopsy and will have been
treated with concurrent radiation therapy and chemotherapy as standard of care for
glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with
oligo features, glioblastoma with primitive neuroectodermal tumor-like components
(GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma or
anaplastic oligoastrocytoma patients. NOTE: Radiation must be completed per the
second eligibility criteria, but chemotherapy is allowed.

- Negative serum pregnancy test done ? 7 days prior to registration only for women
determined to be of childbearing potential by the treating physician.

- Ability to complete questionnaire(s) by themselves or with assistance

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, 2 or 3

- Provide informed written consent

- Willing to return to enrolling institution for follow-up (during the Active
Monitoring Phase of the study)

- Stable dose of corticosteroid ? 14 days prior to registration

Exclusion Criteria:

- Pregnant women, nursing women, men or women of childbearing potential who are
unwilling to employ adequate contraception since this study involves an
investigational agent whose genotoxic, mutagenic and teratogenic effects on the
developing fetus and newborn are unknown.

- History of hypersensitivity to other psychostimulants

- History of steroid psychosis

- History of or currently taking medications for attention deficit hyperactivity
disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient
record and/or self report

- Currently using any other pharmacologic agents or nonpharmacologic interventions to
specifically treat fatigue including psychostimulants, antidepressants, acupuncture,
etc. will be excluded. Note: antidepressants used to treat items other than fatigue
(such as hot flashes or depression) are allowed if the patient has been on a stable
dose for ? 30 days and plans to continue for the duration of the trial.
Erythropoietin agents to treat anemia are allowed. Exercise is allowed.

- Anticipating surgery, laboratory evidence of hypothyroidism with an elevated thyroid
stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L, profound anemia
(hemoglobin level of < 10 g/dL ? 28 days prior to registration), or clinical
depression per physician discretion.

- Active or a history of Tourrette's syndrome or tic disorder

- History of or active glaucoma

- History of intractable epilepsy, or uncontrolled seizure disorder

- Any of the following co-morbid systemic illnesses or other severe concurrent disease
which, in the judgment of the investigator, would make the patient inappropriate for
entry into this study or interfere significantly with the proper assessment of safety
and toxicity of the prescribed regimens:

1. History of myocardial infarction

2. Unstable angina

3. Left ventricular hypertrophy

4. Mitral valve prolapse syndrome

- Receiving any medications or substances that are strong or moderate inhibitors of
cytochrome P450 3A4 (CYP3A4). Use of strong or moderate inhibitors specified in the
protocol are prohibited ? 7 days prior to registration. See the protocol for more
information.

- Receiving any medications or substances that are inducers of CYP3A4. Use of inducers
specified in the protocol are prohibited ? 7 days prior to registration. See the
protocol for more information.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01781468      |      Link to official Clinicaltrials.gov listing
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