ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

NCT00016991 | Completed Phase 2

• 5 other identifiers: 2421DUMC-2421-03-2R2DUMC-2421-01-2NCI-1253CDR0000068639
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

gefitinib DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme in first relapse PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal: * Creatinine less than 1.5 times ULN Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No other uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No prior allergic reactions to compounds of similar chemical or biologic composition to ZD 1839 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Ocular inflammation must be fully treated before study entry PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Must be on stable dose of steroids for at least 1 week Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * At least 1 week since prior surgery Other: * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV * No concurrent enzyme-inducing anticonvulsant drugs

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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Henry S. Friedman, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Study Completion: April 1, 2005
• Last Updated: June 20, 2013

Record last verified: 2009-10

Locations

US (1)