Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To assess the efficacy of immediate release methylphenidate, sustained release methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of cognitive functioning in patients with brain tumors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Patient diagnosed with a brain tumor, either primary or metastatic

2. Patient had prior radiation treatment to the brain

3. Patient is > or = 18 years of age

4. Patient has a Karnofsky performance status (KPS) performance of 70 at baseline

5. Patient is using acceptable birth control methods. Female participants (if of child bearing age and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control, including abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization.

6. Patient must speak and understand English or Spanish

7. Patient has reported cognitive decline and is being considered for stimulant therapy by their neurologist

8. Patient has provided written informed consent to participate in the study prior to enrollment to the study

Exclusion Criteria:

1. History of hypersensitivity reaction to methylphenidate or modafinil

2. History of severe headaches, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, marked anxiety, tension or agitation

3. History of clinically significant pulmonary or cardiac disease

4. Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently greater than 140 mm Hg or diastolic pressure consistently greater than 90 mm Hg

5. Patients with uncontrolled seizures will be excluded

6. Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential

7. Moderate to severe depression (> 20 on Beck Depression Inventory II)

8. If taking antidepressants, patient must be on a stable dose

9. Currently taking psychostimulants, Monoamine oxidase (MAO) inhibitors, or anticoagulants

10. Current use of the following herbals or supplements for fatigue relief (dehydroepiandrosterone (DHEA), S-Adenosyl methionine (SAME), ginkgo, ginseng, St. John's Wort)

11. Any coexisting medical condition or are taking any concomitant medication that is likely to interfere with the safe administration of methylphenidate. Any potential interactions or coexisting medical condition not specified by the protocol will be determined by the prescribing physician as being exclusionary or not.

12. Patients currently taking any erythropoietin type drugs