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Home > "S" Clinical Trials Conditions > SU5416 in Treating Patients With Malignant Mesothelioma  SU5416 in Treating Patients With Malignant Mesothelioma
SU5416 in Treating Patients With Malignant Mesothelioma
For Condition: advanced malignant mesothelioma,epithelial mesothelioma,recurrent malignant mesothelioma,sarcomatous mesothelioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Additional Information:
Study ID Numbers: CDR0000068023; UCCRC-NCI-44,NCI-44
Study Start Date: August 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006014
Other Advanced Malignant Mesothelioma Studies:
1. Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
2. Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
3. Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
4. Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
5. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
Related Studies:
Other advanced malignant mesothelioma Clinical Trials
Other Illinois Clinical Trials
Other Springfield Clinical Trials
SU5416 in Treating Patients With Malignant Mesothelioma
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