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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SU5416

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

NCT ID

NCT00005931

First Posted

June 30, 2000

Last Updated

June 23, 2005

Sponsor

SUGEN

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

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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

Sarcoma, Kaposi, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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