Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

NCT00452868 | Completed Early Phase 1 Results DMC FDA Drug

• 4 other identifiers: CDR0000537049P30CA012197CCCWFU-91305CCCWFU-IRB-00000258
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain. PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain.

Conditions

Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Long-term Effects Secondary to Cancer Therapy in Children; Neurotoxicity; Psychosocial Effects of Cancer and Its Treatment; Radiation Toxicity

Keywords

cognitive/functional effects; neurotoxicity; long-term effects secondary to cancer therapy in children; psychosocial effects of cancer and its treatment; radiation toxicity; childhood central nervous system germ cell tumor; childhood choroid plexus tumor; childhood craniopharyngioma; childhood grade I meningioma; childhood grade II meningioma; childhood grade III meningioma; childhood spinal cord neoplasm; childhood brain stem glioma; childhood cerebellar astrocytoma; childhood medulloblastoma; childhood supratentorial primitive neuroectodermal tumor; childhood visual pathway and hypothalamic glioma; childhood subependymal giant cell astrocytoma; childhood ependymoma; childhood cerebral astrocytoma/malignant glioma

Outcome Measures

Primary Outcomes (1)

• Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks

  Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.

  24 weeks

Study Arms (1)

Donepozil

EXPERIMENTAL

Donepezil 5 milligrams a day for 6 weeks

Drug: Donepezil

Interventions

Donepezil DRUG

Donepezil 5 milligrams a day for 6 weeks

Donepozil

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Prior diagnosis of primary brain tumor
• No type 2 neurofibromatosis
• Underwent fractionated radiotherapy (≥ 23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
• Karnofsky or Lansky performance status 70-100%
• Fertile patients willing to use effective contraception
• Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3
• Stable weight within the past 6 months with no concern of weight loss
• Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated
• Able to speak English
• More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug

You may not qualify if:

• Stereotactic radiosurgery as sole treatment
• Evidence of disease progression by MRI
• Pregnant or nursing
• Attention-deficit/hyperactivity disorder before cancer diagnosis
• Uncontrolled seizures or uncontrolled endocrinopathies
• Uncontrolled comorbidities
• Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent)
• Use of concurrent anticholinergic drugs

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Tufts-NEMC Cancer Center

Boston, Massachusetts, 02111, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neurotoxicity Syndromes; Radiation Injuries; Choroid Plexus Neoplasms; Spinal Cord Neoplasms; Medulloblastoma; Optic Nerve Glioma; Astrocytoma; Familial ependymoma

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

small number (11) analyzed

Results Point of Contact

• Title: Dr. Janet Tooze
• Organization: Wake Forest Baptist Health

jtooze@wakehealth.edu

336-716-0286

Study Officials

• Sharon M. Castellino, MD, FAAP

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: June 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 7, 2018
• Results First Posted: February 28, 2013

Record last verified: 2018-08

Locations

US (2)