Clonidine for Neurocognitive Sequelae

Status:

WITHDRAWN

Clonidine for Neurocognitive Sequelae

Lead Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

Treatment-Related Cancer

Eligibility:

All Genders

5-16 years

Phase:

PHASE1

PHASE2

Brief Summary

The goals of the study are to determine the efficacy of clonidine in the treatment of children with neurocognitive sequelae following the therapy of long term malignancies. In addition, the study hope...

Detailed Description

The long term prognosis for many children diagnosed with brain tumors and other malignancies has improved dramatically over the last decades and is expected to continue to rise as a result of improved...

Eligibility Criteria

Inclusion

Patients with a prior diagnosis of a pediatric malignancy (brain tumors, solid tumors, leukemia/lymphoma) who are in remission, and are \> 3 years from initial diagnosis. Patients must have completed therapy a minimum of 6 months prior to study entry.
Patients must have English as their primary language
Patients must be \>3 and less than or equal to 16 at the time of study enrollment
Patients must fulfill the operational criteria for neurocognitive deficit and have an IQ \> 50.
Patients must be currently enrolled in a school or a learning environment where an adult familiar with the child's academic performance can provide ratings of that performance over the time of the trial.
Patients must have wbc, hemoglobin and platelet parameters which fall within the norms for the patient's age.
Patients must have adequate hepatic function (bilirubin less than or equal to 1.5 mg/dl and SGPT \< 5x normal) and renal function (normal Cr for age/GFR greater than or equal to 70 ml/min/1.73m2)
Patients must be able to swallow gel caps.
Signed informed consent must be obtained according to institutional guidelines. When appropriate the patient will be included in all discussion in order to obtain verbal assent.
Protocol and informed consent must be approved by the local IRB prior to any patient registration and reapproved every 12 months.

Exclusion

Patients who have evidence of a significant neurological abnormality prior to their cancer diagnosis that would affect neuro-behavioral development (such as genetic: Fragile X, Downs syndrome, or acquired disorders: closed head injury)
Patients with a prior (pre-cancer) diagnosis of attention deficit hyperactivity disorder or major depression
Patients who have a medical condition which would preclude the use of clonidine (medicated for hypertension, cardiac conduction disturbances, cerebrovascular disease, or chronic renal failure)
Patients must not have received psychotropic medication (SSRIs, methylphenidate), anxiolytics, or hypnotics within 2 weeks of study entry.
Patients who are receiving concurrent scheduled barbiturates or sedating drugs.
Currently (within 6 months) known to abuse drugs or to be dependent on any drug including alcohol or with a positive urine drug screen.
Women of childbearing age must not be pregnant or lactating. This group is excluded because of teratogenic potential of this agent demonstrated in rat and rabbit models.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00166686

Last Update

January 11 2013

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