- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006014
SU5416 in Treating Patients With Malignant Mesothelioma
A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma
Study Overview
Detailed Description
OBJECTIVES:
I. Determine the objective response rate, median and overall survival, and time to progression in patients with unresectable malignant mesothelioma treated with SU5416.
II. Determine the effect of SU5416 on surrogate biologic endpoints, including microvessel density, tissue proliferative index, apoptosis, vascular endothelial growth factor levels, and tumor perfusion measured by MRI in these patients.
III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 21-45 patients will be accrued for this study within 18-24 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60640
- Louis A. Weiss Memorial Hospital
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Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Central Illinois, S.C.
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Health Care
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Park Ridge, Illinois, United States, 60068
- Division of Hematology/Oncology
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Peoria, Illinois, United States, 61602
- Oncology/Hematology Associates of Central Illinois, P.C.
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Springfield, Illinois, United States, 62701
- Central Illinois Hematology Oncology Center
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Indiana
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Fort Wayne, Indiana, United States, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Inc.
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South Bend, Indiana, United States, 46617
- Michiana Hematology/Oncology P.C.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven malignant mesothelioma (epithelial, sarcomatoid, or mixed subtype) that is not amenable to surgery or radiotherapy
- Measurable disease
- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- Pleural effusions and ascites are not considered measurable lesions
- Only site of measurable disease must not be located within prior radiotherapy port
- Lesion must be accessible for biopsy
History of previously treated CNS metastasis allowed if:
- Neurologically stable
- No requirement for IV or oral steroids or IV anticonvulsants
- No active or residual disease by brain CT or MRI scan
- Patients with neurologic signs or symptoms suggestive of CNS metastasis must have a negative brain CT or MRI scan
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: WHO 0-2
- Life expectancy: At least 12 weeks
- WBC at least 3,000/mm3
- Platelet count at least 75,000/mm3
- Bilirubin no greater than 1.5 mg/dL
- SGOT and SGPT no greater than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
- No uncompensated coronary artery disease on electrocardiogram or physical examination
- No history of myocardial infarction or severe/unstable angina within the past 6 months
- No severe peripheral vascular disease associated with diabetes mellitus
- No deep vein or arterial thrombosis within the past 3 months
- No pulmonary embolism within the past 3 months
- No significant uncontrolled underlying medical or psychiatric illness
- No serious active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Patients are not considered to have active malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse
- No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
PRIOR CONCURRENT THERAPY:
- No more than 1 prior systemic chemotherapy regimen
- At least 4 weeks since prior systemic chemotherapy and recovered
- Prior intrapleural cytotoxic agents (including bleomycin) allowed
- No concurrent chemotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- At least 30 days since prior investigational drug and recovered
- No concurrent investigational drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive SU5416 IV over 1 hour twice weekly.
Courses repeat every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Lung Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Semaxinib
Other Study ID Numbers
- NCI-2012-02351
- UCCRC-10409
- UCCRC-NCI-44
- NCI-44
- CDR0000068023 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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