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SU5416 in Treating Patients With Malignant Mesothelioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006014
First Posted: February 26, 2004
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Malignant Mesothelioma Drug: semaxanib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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):

Enrollment: 45
Study Start Date: August 2000
Study Completion Date: February 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: semaxanib

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006014


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Division of Hematology/Oncology
Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
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
National Cancer Institute (NCI)
Investigators
Study Chair: Hedy L. Kindler, MD University of Chicago
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006014     History of Changes
Other Study ID Numbers: NCI-2012-02351
UCCRC-10409
UCCRC-NCI-44
NCI-44
CDR0000068023 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: July 5, 2000
First Posted: February 26, 2004
Last Update Posted: June 3, 2013
Last Verified: February 2009

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

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Semaxinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action