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Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme

Study Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib in treating patients with 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 (or high-grade glioma that is behaving clinically and/or radiographically like glioblastoma multiforme) - Progressed after first-line therapy (e.g., surgery, chemotherapy, or radiotherapy) PATIENT CHARACTERISTICS: - Karnofsky performance status 60-100% - ANC > 1,500/mm³ - Platelet count > 100,000/mm³ - Hemoglobin > 8.5 g/dL.
  • - ALT and AST < 2 times upper limit of normal (ULN) - Alkaline phosphatase < 2 times ULN.
  • - Bilirubin < 1.5 mg/dL.
  • - Creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - No diagnosis or history of significant renal or hepatic disease.
  • - No contraindication (e.g., mass effect, brain shift) to lumbar puncture procedure.
  • - No active infection.
  • - No diagnosis or history of corneal abnormalities.
  • - No diagnosis or history of malabsorptive syndrome or other disorder affecting gastrointestinal absorption.
- No history of hypersensitivity reactions to midazolam hydrochloride (CYP3A4 biomarker) PRIOR CONCURRENT THERAPY: - See Disease Characteristics

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.

 NCT00227032
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 1
Lead Sponsor

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

 UNC Lineberger Comprehensive Cancer Center
Principal Investigator

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

 Celeste Lindley, PharmDFrances A. Collichio, MD
Principal Investigator Affiliation UNC Lineberger Comprehensive Cancer CenterUNC Lineberger Comprehensive Cancer Center
Agency Class

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

 Other, NIH
Overall Status Terminated
Countries United States
Conditions

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

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES: Primary.

  • - Determine the maximum tolerated dose of erlotinib hydrochloride when administered in escalating doses every 72 hours in patients with progressive glioblastoma multiforme.
Secondary.
  • - Determine the relationship between plasma and cerebrospinal fluid (CSF) concentrations of erlotinib hydrochloride in these patients.
  • - Determine the relationship between plasma and CSF concentrations of erlotinib hydrochloride in patients not receiving concurrent enzyme-inducing antiepileptic drugs (EIAEDs) vs.#46;those receiving concurrent EIAEDs.
  • - Correlate CYP3A4 activity, as measured by midazolam hydrochloride clearance, with plasma clearance of erlotinib hydrochloride in these patients.
  • - Correlate CYP1A2 activity, as measured by the 4-hour paraxanthine (17X)/caffeine (137X) plasma ratio, with plasma clearance of erlotinib hydrochloride in these patients.
  • - Determine, preliminarily, objective response and disease progression in patients treated with erlotinib hydrochloride.
  • - Correlate the presence of EGFRvIII mutation with objective response and disease progression in patients treated with erlotinib hydrochloride.
OUTLINE: This is an open-label, dose-escalation study. Patients are stratified according to use of concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs.#46;no). Patients receive oral erlotinib hydrochloride once every 72 hours for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses* of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined or preliminary results show no direct relationship between plasma and cerebrospinal fluid concentrations. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. NOTE: *Interim enrollment of patients is allowed; these patients receive the current approved dose of erlotinib hydrochloride. Patients undergo blood sample collection periodically on day 13 for pharmacokinetic studies. The pharmacokinetic study comprises midazolam hydrochloride and caffeine clearance assessment and correlation of these assessments with CYP3A4 activity and CYP1A2 activity. Paraffin-embedded and frozen tumor tissue is obtained from patients who underwent prior surgical resection for analysis of wild-type EGFR and EGFRvIII mutation by immunohistochemistry. Quality of life is assessed at baseline and then at 1 month and 6 months. After completion of study therapy, patients are followed periodically.

Arms & Interventions

Arms

Experimental: Subjects receiving EIAEDs

Patients will be stratified according to concurrent use of enzyme inducing anti-epileptic drugs (EIAED)

Experimental: Subjects NOT taking EIAEDs

Patients will be stratified according to concurrent use of enzyme inducing anti-epileptic drugs (EIAED)

Interventions

Drug: - erlotinib hydrochloride

300 mg, per day for subjects taking EIAEDs 150 mg, per day for those NOT taking EIAEDs

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.

Chapel Hill, North Carolina

Status

Address

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295

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