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ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00016991
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Henry S. Friedman, MD
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

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