Full Text View
Tabular View
No Study Results Posted
Related Studies
SU5416 in Treating Patients With Malignant Mesothelioma
This study has been completed.
First Received: July 5, 2000   Last Updated: February 26, 2009   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006014
  Purpose

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.


Condition Intervention Phase
Malignant Mesothelioma
Drug: semaxanib
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006014

Locations
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Division of Hematology/Oncology
Park Ridge, Illinois, United States, 60068
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46617
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068023, UCCRC-10409, UCCRC-NCI-44, NCI-44
Study First Received: July 5, 2000
Last Updated: February 26, 2009
ClinicalTrials.gov Identifier: NCT00006014     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009