Sarcoma Clinical Trial
Official title:
A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
Verified date | October 2018 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 2013 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hematology-Oncology Associates of Illinois | Chicago | Illinois |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment | |
Other | 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 | At baseline and then every time an MRI is performed while on study treatment. | |
Primary | 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 | 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 | At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment | |
Secondary | 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 |
Every 2 months for up to 1 year after study treatment. | |
Secondary | 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 | At the end of study treatment | |
Secondary | 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 |
Every week while on study treatment until 30 days after last treatment. | |
Secondary | 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. | ||
Secondary | Overall Survival (OS) | Overall Survival will be measured from the first treatment on study until death of any cause. | Every 2 months for up to 1 year after study treatment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
Recruiting |
NCT04457258 -
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
|
Early Phase 1 | |
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Recruiting |
NCT04535713 -
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
|
Phase 2 | |
Completed |
NCT03521531 -
Burden and Medical Care of Sarcoma in Germany
|
||
Completed |
NCT02496520 -
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
|
Phase 1/Phase 2 | |
Terminated |
NCT02054104 -
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
|
Phase 1/Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT04052334 -
Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma
|
Phase 1 | |
Completed |
NCT01593748 -
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
Completed |
NCT01879085 -
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
Completed |
NCT01209598 -
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
|
Phase 2 | |
Completed |
NCT04553471 -
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
|
N/A | |
Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 |