Brain and Central Nervous System TumorsPhase 2NCT00348790
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma
A Phase 2 study testing vatalanib in people with Brain and Central Nervous System Tumors and Sarcoma, run by Northwestern University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Sarcoma
- What is being tested?
- vatalanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2006to Jul 2013
- 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
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hematology-Oncology Associates of Illinois
Chicago, Illinois, 60611-2998
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
About this study
Official title: A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.
Secondary
- Determine the 6-month progression-free survival of these patients.
- Describe the response rate and overall survival of these patients.
- Determine the safety of vatalanib in these patients.
- Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
- Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.
OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors, Sarcoma
- Being tested
- vatalanib
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Sarcoma, Meningioma, Hemangiopericytoma, Malignant, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vatalanibDrug
Also called PTK787, ZK 222584
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: vatalanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment
Measured: At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment
Best Overall Response Rate (ORR)
Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply.
Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.
Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.
Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition
Measured: Every 2 months for up to 1 year after study treatment.
To Correlate the Response Rates With Expression of Certain Types of Genes
Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes
Measured: At the end of study treatment
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following:
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal
Measured: Every week while on study treatment until 30 days after last treatment.
Number of Months Patients Survive After Being Treatment on the Study.
Measured: From the date the first patient began treatment until the date the last patient became deceased.
Overall Survival (OS)
Overall Survival will be measured from the first treatment on study until death of any cause.
Measured: Every 2 months for up to 1 year after study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2010
- Study completionJul 2013
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 Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Jeffrey Raizer, Northwestern University
- Investigators
- Jeffrey J. Raizer, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348790
- Sponsor's protocol ID
- NU 05C4
- Other IDs
- STU00005338, NU 05C4
- Status last verified
- Oct 2018
- First submitted
- 5 Jul 2006
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
- ClinicalTrials.gov ID
- NCT00348790
- Acronym / sponsor ID
- NU 05C4
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Posted 27 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.
Secondary
- Determine the 6-month progression-free survival of these patients.
- Describe the response rate and overall survival of these patients.
- Determine the safety of vatalanib in these patients.
- Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
- Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.
OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vatalanib | Experimental | Drug: vatalanibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| vatalanibAlso: PTK787, ZK 222584 | Drug | Vatalanib |
Primary outcome
Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.
Time frame: 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
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.
6 secondary outcomes
Determine Efficacy (Radiographic and Clinical Improvement)
Time frame: At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment
Best Overall Response Rate (ORR)
Time frame: Every 2 months for up to 1 year after study treatment.
To Correlate the Response Rates With Expression of Certain Types of Genes
Time frame: At the end of study treatment
Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas
Time frame: Every week while on study treatment until 30 days after last treatment.
Number of Months Patients Survive After Being Treatment on the Study.
Time frame: From the date the first patient began treatment until the date the last patient became deceased.
Overall Survival (OS)
Time frame: Every 2 months for up to 1 year after study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey J. Raizer, MD principal investigator
Northwestern University
3 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 vatalanib in people with Brain and Central Nervous System Tumors and Sarcoma, run by Northwestern University at 3 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?
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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 27 Oct 2014). 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?
Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. (time frame: 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). 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 26 Oct 2018.