Vatalanib in Treating Patients With Recurrent or Progressive Meningioma (NCT00348790) | Clinical Trial Compass
CompletedPhase 2
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
United States25 participantsStarted 2006-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 2 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Creatinine \< 1.5 mg/dL
* Negative proteinuria dipstick OR total urinary protein ≤ 500 mg AND creatinine clearance ≥ 50 mL/min
* PT, INR, and PTT ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* …
What they're measuring
1
Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.
Timeframe: From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment