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SU5416 in Treating Patients With Malignant Mesothelioma

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
semaxanib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
May 31, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006014
Brief Title
SU5416 in Treating Patients With Malignant Mesothelioma
Official Title
A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
advanced malignant mesothelioma, recurrent malignant mesothelioma, epithelial mesothelioma, sarcomatous mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
semaxanib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedy L. Kindler, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Division of Hematology/Oncology
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Michiana Hematology/Oncology P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States

12. IPD Sharing Statement

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SU5416 in Treating Patients With Malignant Mesothelioma

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