A Phase 2 interventional study of vatalanib in Brain and Central Nervous System Tumors and Sarcoma, sponsored by Northwestern University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Northwestern University · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
226 studies on the registry are indexed under Meningioma; 87 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 161 interventional studies indexed under Meningioma.
Browse Meningioma studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed meningioma, including the following subtypes:
Malignant meningioma
May or may not have neurofibromatosis (NF) type 1 or 2 disease
Progressive or recurrent disease by MRI or CT scan
Recent resection of recurrent or progressive tumor allowed provided both of the following criteria are met:
PATIENT CHARACTERISTICS:
No severe and/or uncontrolled medical conditions that would limit compliance with study requirements, including any of the following:
PRIOR CONCURRENT THERAPY:
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
Also known as: PTK787, ZK 222584
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.
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
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
Time frame: 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
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
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
Time frame: 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
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)
Overall Survival will be measured from the first treatment on study until death of any cause.
Time frame: Every 2 months for up to 1 year after study treatment.
Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels
Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment
Time frame: 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
FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment
Time frame: At baseline and then every time an MRI is performed while on study treatment.
| Milestone | Vatalanib |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
| Milestone | Vatalanib |
|---|---|
| Started | 25 |
| Completed | 0 |
| Not completed | 25 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Disease progression | 14 |
| Withdrew: Adverse event | 4 |
| Withdrew: Required surgery | 2 |
| Withdrew: Unable to travel to study site | 1 |
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.
| Participants | Vatalanib |
|---|---|
| Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment. | 15 |
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
No measurements were reported for this outcome.
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
| Participants | Vatalanib |
|---|---|
| SD | 15 |
| SD on MRI but clinical decline | 2 |
| PD | 5 |
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
No measurements were reported for this outcome.
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
| participants | Vatalanib |
|---|---|
| Dehydration | 1 |
| Deep vein thrombosis | 1 |
| Fatigue | 4 |
| Gastrointestinal | 1 |
| Hypertension | 1 |
| Hyponatremia | 1 |
| Leukopenia | 1 |
| Pain | 1 |
| Rash | 1 |
| Transaminase | 2 |
| Weight loss | 1 |
| months | Vatalanib |
|---|---|
| Number of Months Patients Survive After Being Treatment on the Study. | 29.2 (15 to 50) |
Overall Survival will be measured from the first treatment on study until death of any cause.
| Months | Vatalanib |
|---|---|
| Overall Survival (OS) | 26 (4.27 to 76.75) |
Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment
No measurements were reported for this outcome.
FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vatalanib | — | 6/25 (24%) | 23/25 (92%) |
| Event | Vatalanib |
|---|---|
| DehydrationMetabolism and nutrition disorders | 2/25 |
| Jaw painMusculoskeletal and connective tissue disorders | 1/25 |
| HeadacheNervous system disorders | 1/25 |
| Atrial fibrillationCardiac disorders | 1/25 |
| RashSkin and subcutaneous tissue disorders | 1/25 |
| Scalp woundSkin and subcutaneous tissue disorders | 1/25 |
| VertigoEar and labyrinth disorders | 1/25 |
| NauseaGastrointestinal disorders | 1/25 |
| Event | Vatalanib |
|---|---|
| FatigueGeneral disorders | 19/25 |
| TransaminaseMetabolism and nutrition disorders | 15/25 |
| HeadacheNervous system disorders | 12/25 |
| HypertensionCardiac disorders | 8/25 |
| NauseaGastrointestinal disorders | 6/25 |
| VomitingGastrointestinal disorders | 6/25 |
| PainMusculoskeletal and connective tissue disorders | 6/25 |
| HyperglycemiaMetabolism and nutrition disorders | 6/25 |
| DiarrheaGastrointestinal disorders | 5/25 |
| InsomniaGeneral disorders | 5/25 |
| Age, Customized(participants) | Vatalanib |
|---|---|
| 21-30 | 1 |
| 31-40 | 1 |
| 41-50 | 6 |
| 51-60 | 8 |
| 61-70 years | 8 |
| 71-80 | 0 |
| 81-90 | 1 |
| Sex: Female, Male(Participants) | Vatalanib |
|---|---|
| Female | 10 |
| Male | 15 |
| Region of Enrollment(participants) | Vatalanib |
|---|---|
| United States | 25 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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