Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors

NCT00031798 | Terminated Phase 3 FDA Drug

• 3 other identifiers: REBACDR0000069227CCCWFU-97600NCI-P02-0211
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors. PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.

Conditions

Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Depression; Fatigue; Quality of Life

Keywords

fatigue; depression; quality of life; cognitive/functional effects; recurrent adult brain tumor; adult brain stem glioma; adult glioblastoma; adult tumors metastatic to brain; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult meningioma; adult anaplastic ependymoma; adult myxopapillary ependymoma; adult ependymoblastoma; adult pilocytic astrocytoma; adult subependymoma; adult grade III meningioma; adult giant cell glioblastoma; adult gliosarcoma; adult grade II meningioma

Interventions

methylphenidate hydrochloride DRUG

quality-of-life assessment PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic brain tumor OR * Histologically confirmed primary brain tumor * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Low-grade glioma * Meningioma * Ependymoma * Planned external beam cranial radiotherapy (partial or whole brain) with a total dose of at least 25 Gy in at least 10 fractions of 180-300 cGy each PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * WBC ≥ 1,500/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious medical or psychiatric illness that would preclude study participation * No hypersensitivity to study drug * No history of steroid psychosis * No family history of or active Tourette's Syndrome * No prior or active glaucoma PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior or concurrent chemotherapy allowed Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed except to brain (including stereotactic radiosurgery) * No concurrent craniospinal axis radiotherapy Surgery: * Not specified Other: * No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse * No concurrent anti-depressants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (7)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Depression; Fatigue; Brain Neoplasms; Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Meningioma; Ependymoma; Neuroectodermal Tumors, Primitive; Glioma, Subependymal; Gliosarcoma

Interventions

Methylphenidate; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: May 1, 2006
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (7)