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A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

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Trial Information

A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma


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

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

August 2000

Completion Date:

February 2009

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma



University of Chicago Cancer Research Center Chicago, Illinois  60637
Evanston Northwestern Health Care Evanston, Illinois  60201
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
University of Illinois at Chicago Chicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Oncology/Hematology Associates of Central Illinois, P.C. Peoria, Illinois  61602
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Division of Hematology/Oncology Park Ridge, Illinois  60068