SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma

August 28, 2014 updated by: AIDS Malignancy Consortium

A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.

Study Overview

Status

Completed

Conditions

Sarcoma

Intervention / Treatment

Drug: semaxanib

Detailed Description

OBJECTIVES: I. Determine the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposi's sarcoma. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients. V. Determine the effects of this regimen on overall quality of life and tumor specific symptoms in these patients.

OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study within 12 months.

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Los Angeles, California, United States, 90024
    - UCLA Clinical AIDS Research and Education (CARE) Center
- New York
  - New York, New York, United States, 10021
    - Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven, cutaneous AIDS-related Kaposi's sarcoma (KS) Must have failed at least 1 standard chemotherapy regimen for KS Chemotherapy refractory (progressed during anthracycline-based or paclitaxel therapy) OR Chemotherapy intolerant (hypersensitivity to drug or unacceptable toxicity) HIV positive At least 5 measurable cutaneous lesions No prior radiotherapy or intradermal therapy to indicator lesions OR KS-related generalized edema or edema of the extremities without evidence of active cutaneous lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 500/mm3 Platelet count at least 50,000/mm3 Hepatic: AST no greater than 5.0 times upper limit of normal Bilirubin no greater than 2.0 mg/dL (no greater than 3.0 mg/dL if concurrent indinavir therapy) Renal: No history of renal failure Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within the past year No severe or unstable angina No history of unstable atherosclerotic coronary artery disease requiring coronary or peripheral artery bypass surgery within the past 2 years Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity to Cremophor or Cremophor based drug product No uncontrolled serious infection such as: Pneumocystis carinii pneumonia Toxoplasmic brain abscess CMV retinitis or colitis Cryptococcal meningitis Symptomatic Mycobacterium avium-intracellulare No other active malignancy, except: Basal cell skin cancer Carcinoma in situ of the cervix No cerebral bleed No diabetes mellitus with clinical evidence of severe peripheral vascular disease or diabetic ulcers No other acute or chronic medical or psychiatric condition that would preclude compliance No history of metabolic acidosis from nucleoside analogues Anion gap no greater than 11 (Na - Cl, HCO3)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior immunotherapy for AIDS-related KS and recovered At least 2 weeks since prior biologic therapy for AIDS-related KS No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 2 weeks since prior chemotherapy for AIDS-related KS and recovered No other concurrent systemic chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy for AIDS-related KS No concurrent hormonal therapy (including beta-HCG) Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No prior stereotactic surgery Other: Stable antiretroviral therapy for at least 4 weeks prior to and at least 29 days during the study Concurrent FDA approved antiretroviral agents or expanded access antiretroviral agents allowed At least 3 weeks since other prior investigational agents No concurrent local or topical therapy for AIDS-related KS No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Steven A. Miles, MD, UCLA Clinical AIDS Research and Education (CARE) Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

November 1, 2000

Study Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AMC-022
CDR0000067633 (Other Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.