Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

1. Patients with CML on imatinib, dasatinib or nilotinib (or any other FDA approved tyrosine kinase inhibitor (TKI) for CML)

2. Must be >/= 18 years of age

3. Must have "fatigue worst" on The Brief Fatigue Inventory > or = 4

4. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception (refer to protocol for acceptable methods of contraception). Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control. Both men and women must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.

5. Informed consent must be signed

6. Patient should have at least a complete cytogenetic response (CCyR) sustained for the last 6 months

7. Patient should be receiving stable dose of TKI for at least 3 months (i.e. no increase or decrease in dose during this period) and should not have treatment interruptions for more than 7 consecutive days during this time period unless this was exclusively because of fatigue.

8. Females must have a negative serum pregnancy test within 48 hours prior to beginning treatment on this trial

9. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at baseline

Exclusion Criteria:

1. History of hypersensitivity or allergy to armodafinil, modafinil or any component of the formulation of armodafinil.

2. History of or current seizures, glaucoma, major psychiatric diagnosis (psychiatric illness that required hospitalization), narcolepsy or Tourette's syndrome

3. History of severe headaches or increased agitation within the last 90 days prior to enrollment

4. History of clinically significant uncontrolled pulmonary or cardiac disease (uncontrolled is defined as patients requiring changes in dose and/or start of a new course of treatment in the last 30 days). This may include disease states as congestive heart failure, cardiac arrhythmias, coronary artery disease, chronic obstructive pulmonary disease and asthma)

5. Uncontrolled hypertension. Patients that have not been on a stable treatment dose for the past month or have a systolic blood pressure consistently (consistently is defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg

6. History of fibromyalgia

7. History or current abuse of alcohol or drugs

8. Moderate to severe depression as measured on the Depression Anxiety Stress Scale (DASS-21)

9. If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days

10. Currently taking psychostimulants (including appetite suppressants), L-Monoamine oxidases (MAO) inhibitors, anticoagulant therapy, anticonvulsant therapy or current consumption of alcohol within 8 hours of enrollment.

11. Current use of corticosteroids, stimulants, or other medications used to improve fatigue symptoms. Topical corticosteroids or occasional, intermittent doses of systemic steroids (e.g., for pre-medications, etc) are allowed

12. On clinical trials listing Armodafinil as a prohibited medication within the last 30 days of enrollment

13. Use of the following herbals or supplements for fatigue relief within the last 30 days (including dehydroepiandrosterone (DHEA), SAMe, ginkgo, ginseng, green, black or Chinese tea, ephedra (aka-ma-huang), popotillo and Mormon tea

14. Any coexisting medical condition or taking any concomitant medication that is likely to interfere with the safe administration of armodafinil

15. Hemoglobin < 8 gm/dl at time of enrollment

16. Albumin value 50% lower than the lower limit of normal

17. Evidence of hepatic impairment (total bilirubin > or = 2.5 times Upper limits of normal (ULN), serum glutamate pyruvate transaminase (SGPT) > or = 2.5 times ULN)

18. Evidence of renal impairment (serum creatinine > 2.5 times ULN)

19. If taking opioids, anxiolytics, and/or hypnotics, no changes in dose and/or no start of new course of treatment in the last 30 days

20. Patients who were ever in blast phase of CML

21. Female patients who are pregnant or breastfeeding

22. History of mitral valve prolapse documented by cardiac study.

23. Patients with history or current suicidal ideation

24. Currently taking strong cytochrome P450 3A4 (CYP3A4) inducers (including but not limited to phenobarbital, phenytoin, rifampin,and troglitazone); strong CYP3A4 inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin and grapefruit juice)

25. Patients who have been transplanted and are on immunosuppressive therapies that may interfere with TKI