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Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

Study Purpose

RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

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.
  • - Radiographic evidence of recurrence or progression.
  • - Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor.
  • - Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Not specified.
Life expectancy.
  • - Not specified.
Hematopoietic.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
Hepatic.
  • - Bilirubin no greater than 2 times normal.
  • - Alkaline phosphatase no greater than 2 times normal.
  • - ALT no greater than 3 times normal.
Renal.
  • - BUN no greater than 1.5 times normal OR.
  • - Creatinine no greater than 1.5 times normal.
Other.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - No medical condition that would interfere with oral administration of erlotinib.
  • - No other medical or psychiatric illness that would preclude study therapy.
  • - No active infection.
  • - No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - No concurrent immunotherapy for brain cancer.
  • - No concurrent biologic therapy for brain cancer.
Chemotherapy.
  • - See Disease Characteristics.
  • - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered.
  • - No concurrent chemotherapy for brain cancer.
Endocrine therapy.
  • - Concurrent glucocorticosteroids allowed.
  • - No concurrent hormonal therapy for brain cancer.
Radiotherapy.
  • - See Disease Characteristics.
Surgery.
  • - Not specified.
Other.
  • - No prior epidermal growth factor receptor (EGFR) inhibitor.
  • - No concurrent EGFR inhibitor.
  • - No other concurrent antineoplastic therapy.
  • - No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following: - Gabapentin.
  • - Lamotrigine.
  • - Divalproex.
  • - Felbamate.
  • - Levetiracetam.
  • - Tiagabine.
  • - Topiramate.
- Zonisamide

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.

 NCT00054496
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.

 The Cleveland Clinic
Principal Investigator

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

 Michael A. Vogelbaum, MD, PhD
Principal Investigator Affiliation The Cleveland Clinic
Agency Class

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

 Other
Overall Status Unknown status
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 response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.
  • - Determine the progression-free and overall survival of patients treated with this drug.
OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

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.

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

Site Contact

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

866-223-8100

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