SU5416 in Treating Patients With Malignant Mesothelioma

NCT00006014 | Completed Phase 2

• 5 other identifiers: NCI-2012-02351UCCRC-10409UCCRC-NCI-44NCI-44CDR0000068023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 10

Brief Summary

Phase II trial to study the effectiveness of SU5416 in treating patients who have malignant mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor.

Conditions

Malignant Mesothelioma

Keywords

advanced malignant mesothelioma; recurrent malignant mesothelioma; epithelial mesothelioma; sarcomatous mesothelioma

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: semaxanib

Interventions

semaxanib DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (10)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Division of Hematology/Oncology

Park Ridge, Illinois, 60068, United States

Location

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

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant; Solitary Fibrous Tumor, Pleural

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Solitary Fibrous Tumors; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Study Officials

• Hedy L. Kindler, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: February 26, 2004
• Study Start: August 1, 2000
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2009
• Last Updated: June 3, 2013

Record last verified: 2009-02

Locations

US (10)