Adult Grade I MeningiomaPhase 2NCT00045734
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
A Phase 2 study testing imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Adult Grade I Meningioma and Adult Grade II Meningioma, run by National Cancer Institute (NCI) at 7 sites in United States.
Trial summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma
- What is being tested?
- imatinib mesylate, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2003to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed meningioma
- Benign, malignant, or atypical disease
- Neurofibromatosis (NF) type 1 or 2 allowed
- Hemangiopericytoma allowed
- Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)
- Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease
Show all 52Show fewer
- Newly diagnosed recurrent disease that requires surgical debulking allowed
- Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy
- Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation
- Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months
- Performance status - Karnofsky 60-100%
- More than 8 weeks
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 120,000/mm^3
- Hemoglobin at least 10 g/dL (transfusions allowed)
- No bleeding disorders
- Bilirubin less than 2 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN
- Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN
- Creatinine less than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No deep venous or arterial thrombosis within the past 6 weeks
- No pulmonary embolism within the past 6 weeks
- No serious active infection
- No prior intracranial hemorrhage
- No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
- No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years
- No other significant medical illness that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- At least 1 week since prior interferon or thalidomide
- No concurrent immunotherapy
- Concurrent epoetin alfa allowed
- At least 4 weeks since prior cytotoxic chemotherapy
- At least 2 weeks since prior vincristine
- At least 6 weeks since prior nitrosoureas
- At least 3 weeks since prior hydroxyurea or procarbazine
- No concurrent chemotherapy
- At least 1 week since prior tamoxifen
- No concurrent hormonal therapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- Recovered from prior surgery
- Recovered from all prior therapy
- At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers
- At least 2 weeks since prior drugs that affect hepatic metabolism
- At least 4 weeks since prior investigational agents
- No concurrent warfarin (heparin or low-molecular weight heparin allowed)
- No other concurrent investigational agents
- No concurrent acetaminophen of more than 500 mg/day
- No other concurrent anticancer therapy
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
National Cancer Institute Neuro-Oncology Branch
Bethesda, Maryland, 20814
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
University of California Los Angeles
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53792
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of California San Francisco
San Francisco, California, 94115
About this study
Official title: Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.
SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.
II. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.
- Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs no).
Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 8-12 months.
- Conditions
- Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Adult Meningeal Hemangiopericytoma, Adult Meningioma, Recurrent Adult Brain Tumor
- Being tested
- imatinib mesylate, laboratory biomarker analysis, pharmacological study
- Medical subject headings
- Meningioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Also called CGP 57148, Gleevec, Glivec
Given orally
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Measured: At 6 months
Secondary outcomes (5)
Progression-free Survival According to Response Evaluation Using Macdonald Criteria
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Measured: 3 years
Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0
percentage of patients who had grade 3 or grade 4 adverse events
Measured: Up to 5 years after completion of study treatment
Tumor Response as Assessed by MRI Using Macdonald Criteria
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features
1: complete response; 2: partial response; 3:stable disease; 4:progression
Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved
Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved
Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable
Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Measured: Up to 5 years
Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)
Blood collected before and at 1,2,4 ad 24 hours after ingestion of imatinib on day 8 of cycle 1
result is the measurement of the before dosing on day 8 (trough level) and the 24 hour dosing day 8
Measured: pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9
Determine Survival for Patients Treated With Imatinib Mesylate
survival determined from start of treatment to date of death
Measured: 3 years
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 startFeb 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Grade I MeningiomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patrick Wen, MD, Principal investigator, North American Brain Tumor Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045734
- Sponsor's protocol ID
- NCI-2012-02495
- Other IDs
- NABTC-0108, U01CA062399, CDR0000257267
- Status last verified
- May 2017
- First submitted
- 6 Sep 2002
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma
- ClinicalTrials.gov ID
- NCT00045734
- Acronym / sponsor ID
- NCI-2012-02495
- Conditions
- Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Adult Meningeal Hemangiopericytoma, Adult Meningioma, Recurrent Adult Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed description
PRIMARY OBJECTIVE:
- Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.
SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.
II. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.
- Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs no).
Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 8-12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Drug: imatinib mesylate, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (52 listed)
- Histologically confirmed meningioma
- Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)
- Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease
- Newly diagnosed recurrent disease that requires surgical debulking allowed
- Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| imatinib mesylateAlso: CGP 57148, Gleevec, GlivecGiven orally | Drug | Treatment (imatinib mesylate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (imatinib mesylate) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (imatinib mesylate) |
Primary outcome
6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria
Time frame: At 6 months
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging [MRI]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
5 secondary outcomes
Progression-free Survival According to Response Evaluation Using Macdonald Criteria
Time frame: 3 years
Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0
Time frame: Up to 5 years after completion of study treatment
Tumor Response as Assessed by MRI Using Macdonald Criteria
Time frame: Up to 5 years
Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)
Time frame: pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9
Determine Survival for Patients Treated With Imatinib Mesylate
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma
Grade I Meningioma, Adult, Grade II Meningioma, Adult
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.
Patrick Wen, MD principal investigator
North American Brain Tumor Consortium
7 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 imatinib mesylate, laboratory biomarker analysis and pharmacological study in people with Adult Grade I Meningioma and Adult Grade II Meningioma, run by National Cancer Institute (NCI) at 7 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?
The sponsor lists 52 inclusion and 0 exclusion criteria. 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.