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Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors

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ClinicalTrials.gov Identifier: NCT00025675
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: gefitinib Phase 2

Detailed Description:

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 no) and disease type (for phase II only) (benign meningioma vs malignant meningioma vs hemangiopericytoma vs glioblastoma vs 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ZD1839 FOR Treatment Of Recurrent Or Progressive Malignant Astrocytoma Or Glioblastoma And Recurrent Or Progressive Meningioma: A Phase II Study With A Phase I Component For Patients Receiving EIAEDs
Actual Study Start Date : October 9, 2001
Actual Primary Completion Date : July 5, 2006
Actual Study Completion Date : January 2, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: p450
p450 inhibitor
 Drug: gefitinib
Active Comparator: nonp450
not on p450 inhibitor
 Drug: gefitinib


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival at 6 months [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025675


Locations
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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
NCI - Neuro-Oncology Branch
Bethesda, Maryland, United States, 20892-8200
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0316
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9154
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-6220
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Frank S. Lieberman, MD University of Pittsburgh
More Information
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Publications:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00025675    
Other Study ID Numbers: NABTC-0001 CDR0000068984
U01CA062399 ( U.S. NIH Grant/Contract )
ABTC-0001
NABTC-0001
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent adult brain tumor
adult meningioma
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult pilocytic astrocytoma
adult subependymoma
 adult mixed glioma
adult meningeal hemangiopericytoma
adult grade III meningioma
adult giant cell glioblastoma
adult gliosarcoma
adult grade I meningioma
adult grade II meningioma
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Meningioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action