Vatalanib in Treating Patients With Recurrent or Progressive Meningioma

NCT00348790 | Completed Phase 2 Results DMC

• 2 other identifiers: NU 05C4STU00005338
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Brain and Central Nervous System Tumors; Sarcoma

Keywords

adult grade I meningioma; adult grade II meningioma; adult grade III meningioma; adult malignant hemangiopericytoma; adult anaplastic meningioma; adult papillary meningioma; adult melanocytic lesion; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.

  Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.

  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

Secondary Outcomes (6)

• Determine Efficacy (Radiographic and Clinical Improvement)

  At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment

• Best Overall Response Rate (ORR)

  Every 2 months for up to 1 year after study treatment.

• To Correlate the Response Rates With Expression of Certain Types of Genes

  At the end of study treatment

• Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas

  Every week while on study treatment until 30 days after last treatment.

• Number of Months Patients Survive After Being Treatment on the Study.

  From the date the first patient began treatment until the date the last patient became deceased.

Other Outcomes (2)

• Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels

  MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment

• To Use the FACT BR Questionnaire to Measure Quality of Life

  At baseline and then every time an MRI is performed while on study treatment.

Study Arms (1)

Vatalanib

EXPERIMENTAL

Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached. Patients who are responding may remain on study treatment for 12 months.

Drug: vatalanib

Interventions

vatalanib DRUG

Also known as: PTK787, ZK 222584

Vatalanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 * Fertile patients must use effective contraception during and for up to 6 months after completion of study treatment * No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix, unless in complete remission and off all therapy for that disease for ≥ 3 years * No disease that would obscure toxicity or dangerously alter drug metabolism * No bleeding disorders * No severe and/or uncontrolled medical conditions that would limit compliance with study requirements, including any of the following: * Uncontrolled high blood pressure * History of labile hypertension * History of poor compliance with an antihypertensive regimen * Unstable angina pectoris * Symptomatic congestive heart failure * Myocardial infarction within the past 6 months * Serious uncontrolled cardiac arrhythmia * Uncontrolled diabetes * Active or uncontrolled infection * Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib (i.e., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow tablets) * QTc \> 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Novartis: collaborator

Study Sites (3)

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Sarcoma; Meningioma; Hemangiopericytoma, Malignant; Brain Neoplasms

Interventions

vatalanib

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Brain Diseases; Central Nervous System Diseases

Results Point of Contact

• Title: Jeffrey Raizer, MD
• Organization: Northwestern University

jraizer@nmff.org

312-503-4724

Study Officials

• Jeffrey J. Raizer, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffrey Raizer, MD

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: May 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2013
• Last Updated: October 26, 2018
• Results First Posted: October 27, 2014

Record last verified: 2018-10

Locations

US (3)