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Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors

Study Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of CNS tumors. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or progressive CNS tumors.

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:

  • - Diagnosis of 1 of the following: - Histologically confirmed supratentorial malignant primary glioma.
  • - Glioblastoma multiforme.
  • - Anaplastic astrocytoma.
  • - Anaplastic oligodendroglioma.
  • - Anaplastic mixed oligoastrocytoma.
  • - Malignant astrocytoma not otherwise specified.
  • - Histologically confirmed or radiographically defined recurrent or progressive brain or spinal meningioma, including base of skull or cavernous sinus meningiomas.
  • - Benign, malignant, or atypical.
  • - May include neurofibromatosis type I or II.
  • - Hemangiopericytoma allowed.
  • - Recurrent or progressive disease by MRI or CT scan.
  • - Evidence of true progressive disease by PET or thallium scan, MR spectroscopy, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery (to the target lesion for meningioma and hemangiopericytoma) - Steroid dosage must be stable for at least 5 days prior to scan.
  • - No limitations on the number of prior surgeries, radiotherapy or chemotherapy regimens, or radiosurgery treatments for patients with meningioma or hemangiopericytoma and may include standard external beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery in any combination.
  • - Patients with glioma must have failed prior radiotherapy.
  • - Original histology of low-grade glioma allowed if subsequent confirmation of malignant glioma is made at time of recurrence.
  • - Phase I (closed to accrual as of 09/19/2003): - Prior treatment for no more than 3 prior relapses in patients with glioma.
  • - Phase II: - Measurable disease after prior surgical resection of recurrent or progressive disease.
  • - Prior treatment for no more than 2 prior relapses in patients with glioma.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - More than 8 weeks.
Hematopoietic:
  • - WBC at least 3,000/mm^3.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 120,000/mm^3.
  • - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT less than 1.5 times ULN.
Renal:
  • - Creatinine less than 1.5 mg/dL OR.
  • - Creatinine clearance at least 60 mL/min.
Cardiovascular:
  • - No significant cardiac risk factors within the past 6 months.
Other:
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - No gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6 months.
  • - No active infection.
  • - No concurrent disease that would obscure toxicity or dangerously alter drug metabolism.
  • - No other significant medical illness that would preclude study.
  • - No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - At least 1 week since prior interferon or thalidomide.
  • - No concurrent filgrastim (G-CSF) Chemotherapy: - See Disease Characteristics.
  • - At least 2 weeks since prior vincristine.
  • - At least 6 weeks since prior nitrosoureas.
  • - At least 3 weeks since prior procarbazine.
Endocrine therapy:
  • - At least 1 week since prior tamoxifen.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 4 weeks since prior radiotherapy.
Surgery:
  • - See Disease Characteristics.
  • - At least 7 days since prior surgery for recurrent or progressive tumor and recovered.
Other:
  • - Recovered from prior therapy.
  • - No prior gefitinib or other epidermal growth factor receptor inhibitor.
  • - At least 1 week since prior isotretinoin.
  • - At least 1 week since other prior noncytotoxic agents (except radiosensitizers) - At least 4 weeks since prior investigational agents.
- Concurrent low-molecular weight heparin or warfarin for deep vein thrombosis or pulmonary embolism allowed

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.

NCT00025675
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.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

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

Frank S. Lieberman, MD
Principal Investigator Affiliation University of Pittsburgh
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 maximum tolerated dose of gefitinib in patients with recurrent or progressive supratentorial malignant gliomas or brain or spinal meningiomas receiving enzyme-inducing antiepileptic drugs (EIAEDs).
(Phase I of the study closed to accrual as of 09/19/2003).
  • - Determine the toxic effects of this drug in these patients.
  • - Determine the pharmacokinetics of this drug in patients receiving EIAEDs.
  • - Determine the efficacy of this drug in terms of 6-month progression-free survival of these patients.
  • - Determine the safety profile of the phase II dose of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs.#46;no) and disease type (for phase II only) (benign meningioma vs.#46;malignant meningioma vs.#46;hemangiopericytoma vs.#46; glioblastoma vs.#46;other anaplastic glioma). (Phase I closed to accrual as of 09/19/2003). Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients (who are receiving EIAEDs) receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for the phase I portion of this study within 10 months . (Phase I closed to accrual as of 09/19/2003). A total of 48 patients will be accrued for the phase II portion of this study within 6-8 months.

Arms & Interventions

Arms

Active Comparator: p450

p450 inhibitor

Active Comparator: nonp450

not on p450 inhibitor

Interventions

Drug: - gefitinib

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.

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095

UCSF Comprehensive Cancer Center, San Francisco, California

Status

Address

UCSF Comprehensive Cancer Center

San Francisco, California, 94143

Bethesda, Maryland

Status

Address

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182

NCI - Neuro-Oncology Branch, Bethesda, Maryland

Status

Address

NCI - Neuro-Oncology Branch

Bethesda, Maryland, 20892-8200

Boston, Massachusetts

Status

Address

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Ann Arbor, Michigan

Status

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0316

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

Pittsburgh, Pennsylvania

Status

Address

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232

Dallas, Texas

Status

Address

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9154

Houston, Texas

Status

Address

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-6220

Madison, Wisconsin

Status

Address

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792