Official Title: “A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma”

RATIONALE: SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma.

Study Type: Interventional

Study Design: Treatment

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.

• 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 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3
• Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: 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 Pulmonary: No pulmonary embolism within the past 3 months Other: 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: Biologic therapy: Not specified Chemotherapy: 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 Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease
• Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drug and recovered No concurrent investigational drug

Lead Sponsor: University of Chicago

Cancer Care Specialists of Central Illinois, S.C.

Decatur Illinois 62526 United States

Central Illinois Hematology Oncology Center

Springfield Illinois 62701 United States

Division of Hematology/Oncology

Park Ridge Illinois 60068 United States

Evanston Northwestern Health Care

Evanston Illinois 60201 United States

Louis A. Weiss Memorial Hospital

Chicago Illinois 60640 United States

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria Illinois 61602 United States

University of Chicago Cancer Research Center

Chicago Illinois 60637-1470 United States

University of Illinois at Chicago

Chicago Illinois 60612 United States

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne Indiana 46885-5099 United States

Michiana Hematology/Oncology P.C.

South Bend Indiana 46617 United States

Overall Clinical Trial Officials and Contacts

Hedy L. Kindler, MD Study Chair University of Chicago  

Information obtained from ClinicalTrials.gov on May 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00006014

Study ID Number: CDR0000068023

ClinicalTrials.gov Identifier: NCT00006014

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database