Clinical trial · Interventional
Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors
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
NCT00025675CI-TRIAL-00033416completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- p450
- description
- p450 inhibitor
- interventionNames
- Drug: gefitinib
- type
- ACTIVE_COMPARATOR
- label
- nonp450
- description
- not on p450 inhibitor
- interventionNames
- Drug: gefitinib
Primary outcomes (1)
- measure
- Progression-free survival at 6 months
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 allowedReferences
Publications (2)
- BACKGROUNDNorden 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 19562255
- BACKGROUNDLassman 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 16278407