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
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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 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: p450
p450 inhibitor
|
Drug: gefitinib |
Active Comparator: nonp450
not on p450 inhibitor
|
Drug: gefitinib |
- Progression-free survival at 6 months [ Time Frame: 6 months ]

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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 |
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
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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

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
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 |
Study Chair: | Frank S. Lieberman, MD | University of Pittsburgh |
Publications:
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT00025675 History of Changes |
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:
Glioblastoma Astrocytoma Nervous System Neoplasms Central Nervous System Neoplasms Meningioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Neoplasms, Vascular Tissue Meningeal Neoplasms Gefitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |