Phase 2
N=25
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
Brain and Central Nervous System Tumors · Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00348790 ↗Enrolled (actual)
25
Serious AEs
24.0%
Results posted
Oct 2014
Primary outcome: Primary: Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vatalanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. |
15 | — |
| SECONDARY Determine Efficacy (Radiographic and Clinical Improvement) |
— | — |
| SECONDARY Best Overall Response Rate (ORR) |
15; 2; 5 | — |
| SECONDARY To Correlate the Response Rates With Expression of Certain Types of Genes |
— | — |
| SECONDARY Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas |
1; 1; 4; 1; 1; 1 | — |
| SECONDARY Number of Months Patients Survive After Being Treatment on the Study. |
29.2 | — |
| SECONDARY Overall Survival (OS) |
26 | — |
Summary
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed meningioma, including the following subtypes:
- Benign meningioma
- Malignant meningioma
- Steroid dosage stable for ≥ 5 days
- Atypical meningiomas
- Hemangiopericytoma
- May or may not have neurofibromatosis (NF) type 1 or 2 disease
- Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been stable for the past 6 months
- Progressive or recurrent disease by MRI or CT scan
- Prior radiotherapy allowed provided evidence of disease progression is documented by positron emission tomography, thallium scanning, magnetic resonance spectroscopy, or surgery to rule out radiation necrosis for patients treated with radiosurgery
- Recent resection of recurrent or progressive tumor allowed provided both of the following criteria are met:
- At least 4 weeks since prior surgery and recovered
- Evaluable residual disease
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- SGOT and SGPT 450 (male) or > 470 (female)
- Congenital or acquired long QTc syndrome
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 4 weeks since prior radiotherapy, including external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery
- At least 4 weeks since prior investigational agents
- More than 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)
- More than 4 weeks since prior immunotherapy
- More than 2 weeks since prior noncytotoxic or biologic therapies
- At least 2 weeks since prior drugs that affect hepatic metabolism (steroids should be tapered off if not clinically indicated)
- At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsant drugs
- No prior antivascular endothelial growth factor therapy
- No other concurrent investigational agents or anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy)
- No concurrent warfarin
- No concurrent grapefruit or grapefruit juice
Data sourced from ClinicalTrials.gov (NCT00348790). 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.