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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care Active 6 to 18 NCI, Other MEMFX2 RO1-CA078957, UO1-CA81445, P30-CA2Z1765, NCT00576472

Trial Description

Summary

Children surviving some types of cancer have a higher risk of developing learning problems after cancer treatment than do children who have not had cancer or its treatment. Cancer treatment may cause problems with learning, attention, and memory. The purpose of this study is to identify brain changes that may underlie learning problems in cancer survivors and investigate whether methylphenidate (a stimulant medication) may reduce these problems.

Subjects who have had treatment for acute lymphoblastic leukemia (ALL) or a brain tumor will be asked to take part in this research study. Siblings of some subjects will also be asked to take part, so that their results can be compared with those of children who have had cancer treatment. We hypothesize that children receiving more aggressive therapy will have lower white matter brain volumes and these volumes will be significantly lower than age-matched siblings. We also hypothesize that children who take methylphenidate will show improvements on teacher and parent report measures of attention and social skills.

Further Study Information

This study is a multi-phase, multi-site methylphenidate (MPH) trial in childhood cancer survivors. Study participants that meet inclusion and exclusion criteria are screened to ensure that they have adequate global cognitive functioning (IQ > 50) and have academic and attention difficulties that might be managed with MPH. Following the screening phase, qualifying participants take part in a two-day, in-clinic, double-blind, cross-over trial during which they receive MPH (0.6 mg/kg; maximum dose, 20 mg) and placebo (inert substance) in a randomly assigned order. Patients who do not have a significant adverse reaction during the two-day trial go on to participate in a randomized, double-blind, placebo-controlled, three-week home cross-over trial consisting of placebo, low-dose MPH (0.3 mg/kg; maximum dose, 10 mg bid), and moderate-dose MPH (0.6 mg/kg; maximum dose, 20 mg bid). Patients are then selected for participation in a 12-month open-label MPH trial if they show improvement over placebo on a parent and/or teacher rating of attention during the three-week home cross-over trial. The 12-month open-label MPH trial includes individually titrated MPH dosing to maximize clinical benefit, monthly monitoring of side effects and regular acquisition of parent and teacher ratings of attention and behavior. Laboratory measures of intellectual function, attention and memory are conducted at the end of the 12-month trial.

Eligibility Criteria

Inclusion Criteria:

• Age: 6 to 18 years old.

• Active subject at St. Jude Children's Research Hospital, or is an age-matched sibling control subject.

• If a subject, received treatment for brain tumor or ALL with either radiation therapy and/or chemotherapy directed at the brain.

• If a subject, at least 12 months post-completion of antineoplastic therapies

• If a subject, no evidence of malignancy, or continuously stable disease since completion of therapy

• English as a primary language

• Informed consent

Exclusion Criteria:

• Glaucoma

• Patient or immediate family member with a history of Tourette's syndrome

• Current antidepressant, anxiolytic, antipsychotic or stimulant therapy

• History of substance abuse

• Recent history of uncontrolled seizures

• Uncorrected hypothyroidism

• Previously or currently randomized on COGRM1 intervention arm

• Previously diagnosed with ADHD, or, if a patient, diagnosed with ADHD prior to diagnosis of malignancy

Trial Contact Information

Trial Lead Organizations/Sponsors

St. Jude Children's Research Hospital

Heather M Conklin

Principal Investigator

Heather M Conklin, PhD		Ph: 1-866-278-5833
		Email: info@stjude.org

U.S.A.
Tennessee
	Memphis
	St. Jude Children's Research Hospital
		Heather M Conklin, PhD

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00576472
Information obtained from ClinicalTrials.gov on January 07, 2009