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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SU5416
Sponsored by
SUGEN
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Enzyme Inhibitors, SU 5416, Protein-Tyrosine Kinase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alison L. Hannah

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 30, 2000
Last Updated
June 23, 2005
Sponsor
SUGEN
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1. Study Identification

Unique Protocol Identification Number
NCT00005931
Brief Title
SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment
Official Title
A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2000
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
SUGEN

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Enzyme Inhibitors, SU 5416, Protein-Tyrosine Kinase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SU5416

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Alison L. Hannah
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States

12. IPD Sharing Statement

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

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