- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005931
SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment
June 23, 2005 updated by: SUGEN
A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma
The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).
Study Overview
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.
Study Type
Interventional
Enrollment
30
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
-
-
California
-
South San Francisco, California, United States, 94080
- Alison L. Hannah
-
-
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
No
Genders Eligible for Study
All
Description
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.
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
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 Registration Dates
First Submitted
June 30, 2000
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- DNA Virus Infections
- Herpesviridae Infections
- Neoplasms, Vascular Tissue
- Sarcoma
- Sarcoma, Kaposi
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Semaxinib
Other Study ID Numbers
- 310B
- SU5416.027
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.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on SU5416
-
SUGENCompletedHIV Infections | Sarcoma, KaposiUnited States
-
Clover Biopharmaceuticals AUS Pty LtdTerminated
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)TerminatedBrain and Central Nervous System TumorsUnited States
-
National Cancer Institute (NCI)TerminatedStage IV Renal Cell Cancer | Recurrent Renal Cell CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)CompletedStage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Adenocarcinoma of the Rectum | Stage III Colon Cancer | Stage III Rectal Cancer | Adenocarcinoma of the ColonUnited States
-
National Cancer Institute (NCI)CompletedOvarian Cancer | Peritoneal Neoplasm | Fallopian Tube NeoplasmUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Melanoma | Stage IV MelanomaUnited States
-
National Cancer Institute (NCI)CompletedChronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Previously Treated Myelodysplastic Syndromes | Refractory Anemia With Excess Blasts | Refractory Anemia With Excess Blasts in TransformationUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States