SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment

The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Completed

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Key information

Conditions

Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases DNA Virus Infections Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue RNA Virus Infections Retroviridae Infections Sarcoma Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alison L. Hannah

South San Francisco, California, 94080, United States

About this study

Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients may be eligible for this study if they:

Are at least 18 years old.
Have KS.
Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten better or could not tolerate treatment therapy.
Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related edema (swelling) without sores, or KS-related edema of the arms and legs.
Agree to use an effective method of birth control during the study.

Exclusion criteria

Patients will not be eligible for this study if they:

Are pregnant or breast-feeding.
Are allergic to Cremophor.

Treatment and study plan

SU5416

Drug

Sponsors and collaborators

Lead sponsor

SUGEN

Industry

Registry information

Official study title

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

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed