Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

SU5416 in Treating Patients With Malignant Mesothelioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UCCRC-10409 UCCRC-NCI-44, NCI-44, NCT00006014, 44

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.

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

Expected Enrollment

Approximately 21-45 patients will be accrued for this study within 18-24 months.

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Hedy Kindler, MD, Protocol chair		Ph: 773-702-0360; 888-824-0200

Registry Information
Official Title		A Phase II Trial of SU5416 (NSC# 696819) in Patients with Malignant Mesothelioma
Trial Start Date		2000-08-15
Trial Completion Date		2009-02-20
Registered in ClinicalTrials.gov		NCT00006014
Date Submitted to PDQ		2000-05-26
Information Last Verified		2009-02-20
NCI Grant/Contract Number		CA14599, CA63187

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