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ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00016991
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Duke University

Tracking Information
First Submitted Date  ICMJE June 6, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE June 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00016991 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse
Official Title  ICMJE A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Drug: gefitinib
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00016991
Other Study ID Numbers  ICMJE 2421
DUMC-2421-03-2R2
DUMC-2421-01-2
NCI-1253
CDR0000068639 ( Other Identifier: NCI )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henry Friedman, MD, Duke UMC
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Henry S. Friedman, MD Duke University
PRS Account Duke University
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP