Brain and Central Nervous System TumorsPhase 2NCT00025675
Gefitinib in Treating Patients With Recurrent or Progressive CNS Tumors
A Phase 2 study testing gefitinib in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 12 sitesUnited States
- Study dates
- 9 Oct 2001to 2 Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0316
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
NCI - Neuro-Oncology Branch
Bethesda, Maryland, 20892-8200
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9154
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-6220
UCSF Comprehensive Cancer Center
San Francisco, California, 94143
About this study
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
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- gefitinib
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Meningioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma, Subependymal, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinibDrug
| Study group | Role | What they receive |
|---|---|---|
| p450 | Active comparator | p450 inhibitor Receives: Drug: gefitinib |
| nonp450 | Active comparator | not on p450 inhibitor Receives: Drug: gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start9 Oct 2001
- Primary completion5 Jul 2006
- Study completion2 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frank S. Lieberman, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025675
- Sponsor's protocol ID
- NABTC-0001 CDR0000068984
- Other IDs
- U01CA062399, ABTC-0001, NABTC-0001
- Status last verified
- Jun 2018
- First submitted
- 11 Oct 2001
- Last updated
- 26 Jun 2018
- Results posted
- No
Publications
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.
PubMed 19562255Lassman 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.
PubMed 16278407
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00025675
- Acronym / sponsor ID
- NABTC-0001 CDR0000068984
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult meningioma, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult pilocytic astrocytoma, adult subependymoma, adult mixed glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Oct 2001 (actual)
- Primary completion
- 5 Jul 2006 (actual)
- Study completion
- 2 Jan 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| p450 | Active comparator | Drug: gefitinibp450 inhibitor |
| nonp450 | Active comparator | Drug: gefitinibnot on p450 inhibitor |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gefitinib | Drug | nonp450, p450 |
Primary outcome
Progression-free survival at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 19562255Norden 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.
- Background: PubMed 16278407Lassman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank S. Lieberman, MD study chair
University of Pittsburgh
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00025675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.