Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
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.
OBJECTIVES:
Primary
- Determine the impact of donepezil hydrochloride on cognitive function in pediatric
patients with primary brain tumors previously treated with cranial radiotherapy.
Secondary
- Assess health-related quality of life of patients treated with this drug.
- Assess function and quality of life of the families of patients treated with this drug.
- Determine the physiologic effects of radiotherapy on cerebrovascular hemodynamics in
patients treated with this drug.
- Determine the toxicity of donepezil hydrochloride in these patients.
OUTLINE: This is a multicenter, pilot, open-label, controlled study.
Patients receive oral donepezil hydrochloride once daily or once every other day for up to 24
weeks in the absence of disease progression or unacceptable toxicity. After completion of 6
weeks of study therapy, patients are evaluated for toxicity. Patients experiencing no adverse
effects from treatment may continue receiving donepezil hydrochloride at a higher dose for 18
more weeks.
Patients undergo measurement of cognitive function (by neurocognitive testing), behavioral
adjustment and social competency (by parent-reported questionnaires), health-related quality
of life (by child- and parent-reported questionnaires), and vascular dynamics (by
transcranial Doppler ultrasound) at baseline and at weeks 12, 24, and 36. Family function and
family quality of life are assessed at baseline and at week 24.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00006080 -
Fenretinide in Treating Patients With Recurrent Malignant Glioma
|
Phase 2 | |
| Recruiting |
NCT00887146 -
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00621686 -
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Terminated |
NCT00227032 -
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
| Terminated |
NCT00243022 -
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
|
Phase 2 | |
| Active, not recruiting |
NCT00278278 -
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
|
Phase 3 | |
| Active, not recruiting |
NCT00087815 -
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
|
N/A | |
| Completed |
NCT00416819 -
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
|
N/A | |
| Completed |
NCT00052286 -
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
|
N/A | |
| Completed |
NCT00006093 -
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00004129 -
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00003417 -
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
|
Phase 1/Phase 2 | |
| Completed |
NCT00003464 -
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
| Completed |
NCT00003484 -
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
|
Phase 1 | |
| Completed |
NCT00003020 -
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
|
Phase 1 |