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ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Duke University Identifier:
First received: June 6, 2001
Last updated: June 19, 2013
Last verified: October 2009

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.

Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme

Resource links provided by NLM:

Further study details as provided by Duke University:

Study Start Date: June 2001
Study Completion Date: April 2005
Detailed Description:


  • Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first relapse.
  • Determine the pharmacokinetics and toxicity of this drug in these patients.
  • Assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug.

OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed glioblastoma multiforme in first relapse



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 12 weeks


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine less than 1.5 times ULN


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


Biologic therapy:

  • Not specified


  • 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


  • At least 4 weeks since prior radiotherapy and recovered


  • At least 1 week since prior surgery


  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV
  • No concurrent enzyme-inducing anticonvulsant drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00016991

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Study Chair: Henry S. Friedman, MD Duke University
  More Information

Responsible Party: Henry Friedman, MD, Duke UMC Identifier: NCT00016991     History of Changes
Other Study ID Numbers: 2421  DUMC-2421-03-2R2  DUMC-2421-01-2  NCI-1253  CDR0000068639 
Study First Received: June 6, 2001
Last Updated: June 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
recurrent adult brain tumor
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016