NCI Community Oncology Research Program - Protocol Summary
CTSU Alliance A221101 - "A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil;) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Cancer Control Clinical Trial
CANCER TYPE: Brain/CNS
RESEARCH BASE: CTSU Alliance A221101
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
Glioma (high-grade), clinically stable post RT & chemo, >=6 on worst fatigue scale; Armodafinil (2 dosage arms) vs. placebo to reduce cancer-related fatigue. DCP-001 Eligible
THIS TRIAL IS DCP-001 ELIGIBLE
NOTE: All staff members who will be administering neurocognitive testing must be credentialed (see §4.1). Individuals previously credentialed for any of the studies in §126.96.36.199 need to be partially re-certified. See §188.8.131.52 for individuals not previously credentialed.
Treatment Plan (Supplied Drug: Armodafinil/placebo)
Armodafinil: 150mg, PO, QD, x 8 wks
Placebo: 1 tablet, PO, QD, x 8 wks
Armodafinil: 250mg, PO QD, x 8 wks
Unacceptable AEs or pt refusal at any time ---> Off Study
- 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 (excluding stereotactic radiosurgery) >21 days prior to registration. NOTE: Clinical stability will be defined as a stable or improved KPS compared to the prior month.
- ≥ 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, see appendix III Question 3). It is not required for the patient to complete the entire BFI to meet this criterion.
- 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 Section 3.1.2, but chemotherapy is allowed.
Patients who are currently using Optune® device will be eligible to participate in this trial.
- Negative serum pregnancy test done ≤ 7 days prior to registration only for women determined to be of childbearing potential by their treating physician.
- Ability to complete questionnaire(s) by themselves or with assistance.
- ECOG Performance Status (PS) of 0, 1, 2 or 3 (Appendix XV).
- 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.
- None of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
- No history of hypersensitivity to other psychostimulants.
- No history of steroid psychosis.
- Not currently taking medications for attention deficit hyperactivity disorder, history of or currently taking medications for severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report. Note: Patients who had childhood ADHD and no longer require treatment will be eligible to participate.
- Not 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 prior to registration and plans to continue for the duration of the trial. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.
- Not anticipating surgery
- No uncontrolled hypothyroidism, profound anemia (hemoglobin level of <10 g/dL ≤ 28 days prior to registration), or untreated clinical depression per physician discretion. Patients with stable, controlled depression or receiving treatment for hypothyroidism will be eligible, if they have been on a stable dose for the past 30 days and plan to continue for the duration of the trial.
- No history of Tourrette’s syndrome or tic disorder.
- No history of or active glaucoma.
- No history of intractable epilepsy.
- None 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:
• History of myocardial infarction
• Unstable angina
• Left ventricular hypertrophy
• Mitral valve prolapse syndrome
- Not receiving any medications or substances that are strong or moderate inhibitors of CYP3A4.
- Not receiving any medications or substances that are inducers of CYP3A4.