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

Purpose

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

Condition	Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: SU5416	Phase II

MedlinePlus related topics:

AIDS Cancer Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for:

Semaxanib Tyrosine SU 5416

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

30

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005931

Locations


United States, California
	Alison L. Hannah
	South San Francisco, California, United States, 94080

Sponsors and Collaborators

SUGEN

More Information

Study ID Numbers:	310B, SU5416.027
First Received:	June 30, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005931
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Skin Neoplasms

Sarcoma, Kaposi

Acquired Immunodeficiency Syndrome

Antineoplastic Agents

Enzyme Inhibitors

SU 5416

Protein-Tyrosine Kinase

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Malignant mesenchymal tumor

Acquired Immunodeficiency Syndrome

Sarcoma, Kaposi

Skin Neoplasms

SU 5416

Soft tissue sarcomas

Immunologic Deficiency Syndromes

Herpesviridae Infections

Virus Diseases

Neoplasms, Connective and Soft Tissue

Kaposi sarcoma

HIV Infections

Sexually Transmitted Diseases

Sarcoma

DNA Virus Infections

Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Infection

Protein Kinase Inhibitors

Angiogenesis Inhibitors

Pharmacologic Actions

Neoplasms

Therapeutic Uses

Lentivirus Infections

Neoplasms, Vascular Tissue

Growth Inhibitors

Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	SUGEN
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00005931