NCT00025675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2001

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2006

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2010

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

4.7 years

First QC Date

October 11, 2001

Last Update Submit

June 22, 2018

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult meningiomaadult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult pilocytic astrocytomaadult subependymomaadult mixed gliomaadult meningeal hemangiopericytomaadult grade III meningiomaadult giant cell glioblastomaadult gliosarcomaadult grade I meningiomaadult grade II meningioma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival at 6 months

    6 months

Study Arms (2)

p450

ACTIVE COMPARATOR

p450 inhibitor

Drug: gefitinib

nonp450

ACTIVE COMPARATOR

not on p450 inhibitor

Drug: gefitinib

Interventions

gefitinibDRUG
nonp450p450

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Neuro-Oncology Branch

Bethesda, Maryland, 20892-8200, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0316, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

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

Dallas, Texas, 75390-9154, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-6220, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • Norden AD, Raizer JJ, Abrey LE, Lamborn KR, Lassman AB, Chang SM, Yung WK, Gilbert MR, Fine HA, Mehta M, Deangelis LM, Cloughesy TF, Robins HI, Aldape K, Dancey J, Prados MD, Lieberman F, Wen PY. Phase II trials of erlotinib or gefitinib in patients with recurrent meningioma. J Neurooncol. 2010 Jan;96(2):211-7. doi: 10.1007/s11060-009-9948-7. Epub 2009 Jun 28.

    PMID: 19562255BACKGROUND

  • Lassman AB, Rossi MR, Raizer JJ, Abrey LE, Lieberman FS, Grefe CN, Lamborn K, Pao W, Shih AH, Kuhn JG, Wilson R, Nowak NJ, Cowell JK, DeAngelis LM, Wen P, Gilbert MR, Chang S, Yung WA, Prados M, Holland EC. Molecular study of malignant gliomas treated with epidermal growth factor receptor inhibitors: tissue analysis from North American Brain Tumor Consortium Trials 01-03 and 00-01. Clin Cancer Res. 2005 Nov 1;11(21):7841-50. doi: 10.1158/1078-0432.CCR-05-0421.

    PMID: 16278407BACKGROUND

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsMeningiomaGlioblastomaAstrocytomaOligodendrogliomaGlioma, SubependymalGliomaGliosarcoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueMeningeal NeoplasmsNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialEpendymoma

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Frank S. Lieberman, MD

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

October 9, 2001

Primary Completion

July 5, 2006

Study Completion

January 2, 2010

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(12)