SU5416 in Treating Patients With Malignant Mesothelioma
Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring advanced malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma
Eligibility Criteria
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
Sites / Locations
- University of Illinois at Chicago
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Cancer Care Specialists of Central Illinois, S.C.
- Evanston Northwestern Health Care
- Division of Hematology/Oncology
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- Michiana Hematology/Oncology P.C.
Arms of the Study
Arm 1
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.