Phase 2
N=23
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Adult Grade I Meningioma · Adult Grade II Meningioma · Adult Grade III Meningioma · Adult Meningeal Hemangiopericytoma · Adult Meningioma
Bottom Line
View on ClinicalTrials.gov: NCT00045734 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: 6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria — 29.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- imatinib mesylate (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria |
29.4 | — |
| SECONDARY Progression-free Survival According to Response Evaluation Using Macdonald Criteria |
2 | — |
| SECONDARY Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0 |
2.3 | — |
| SECONDARY Tumor Response as Assessed by MRI Using Macdonald Criteria |
10; 9 | — |
| SECONDARY Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics) |
2129; 2248 | — |
| SECONDARY Determine Survival for Patients Treated With Imatinib Mesylate |
16.8 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00045734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.