RATIONALE: Dexmethylphenidate may be effective in relieving fatigue and improving neurobehavioral changes such as loss of concentration and memory in patients with cancer who have received chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of dexmethylphenidate in treating patients who have fatigue and neurobehavioral changes after undergoing chemotherapy.

Condition	Treatment or Intervention	Phase
Fatigue cognitive/functional effects unspecified adult solid tumor, protocol specific	Drug: dexmethylphenidate  Procedure: complications of therapy assessment/management  Procedure: fatigue assessment/management  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the efficacy of dexmethylphenidate, in terms of reduced fatigue and improved neurobehavioral function, in cancer patients with chemotherapy-induced fatigue and neurobehavioral impairment.
• Determine the safety of this drug in these patients.
• Determine the efficacious dose range required to maintain the effectiveness of this drug in these patients.

OUTLINE: This is a randomized, single- and double-blind, placebo-controlled, parallel-group, multicenter study. Treatment is divided into single-blind prerandomization and double-blind treatment phases.

• Patients receive oral study drug twice daily for 7 days. Patients complete the Clinical Global Impression and Clinical Global Impression-Improvement scales at baseline and at completion of the pre-randomization phase. Patients with no improvement on these scales proceed to the double-blind treatment phase.
• Patients are randomized to 1 of 2 treatment arms.
• Arm I: Patients receive oral dexmethylphenidate twice daily.
• Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

Patients in both arms complete efficacy assessments at baseline, weekly during treatment, and at end of treatment.

PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer
• No primary or metastatic brain tumors
• At least 4 prior courses of cytotoxic chemotherapy
• No more than 2 months since completion of chemotherapy
• Absence of a focal neurological deficit by physical and neurological examination
• Must meet all of the following parameters:
• Cancer-related fatigue (CRF) as determined by International Classification of Disease-10 Criteria for CRF
• Score of at least 20 on Mini-Mental Status Exam
• Score less than 18 on Beck Depression Inventory-II
• Score of at least 3 on Clinical Global Impression-Severity

PATIENT CHARACTERISTICS: Age

• 18 to 70

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Neurologic

• No history of seizure disorder
• No severe mental impairment that would preclude study compliance
• No major psychiatric illness (e.g., suicidal ideation) that would preclude study
• None of the following:
• Attention-deficit disorder
• Learning disabilities
• Special education support

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of drug or alcohol abuse
• Able to speak and understand English
• At least 8^th-grade education
• No concurrent symptoms of menopause
• No other concurrent severe acute or chronic medical condition that would preclude study
• No medical contraindication to the use of dexmethylphenidate or methylphenidate, including:
• Marked anxiety
• Tension
• Agitation
• Glaucoma
• Diagnosis or family history of Tourette's syndrome
• Presence of motor or vocal tics

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• No prior prophylactic cranial radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior investigational drugs
• No prior dexmethylphenidate
• No prior methylphenidate
• More than 30 days since prior monoamine oxidase inhibitors (MAOIs)
• No concurrent MAOIs
• No concurrent opioids or narcotic-like drugs
• Concurrent antidepressants (e.g., tricyclics, selective serotonin reuptake inhibitors) allowed if dose has been stable for at least the past 6 weeks
• No concurrent anticancer therapy
• No concurrent new treatment may be initiated after study enrollment
• No concurrent stimulant medication (e.g., racemic methylphenidate, d-amphetamine, or mixed amphetamine salts [Adderall])

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095,  United States

Study chairs or principal investigators

John A. Glaspy, MD, MPH,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000258509; UCLA-0204034; CELGENE-d-MPH-COG-002
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052533
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08