A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Alitretinoin

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Antineoplastic Agents

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV positive status and histologic confirmation of KS. CD4 count > 200 mm3 (required of one-half of patients). Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions. Acceptable organ system function. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. Prior Medication: Excluded: Systemic therapy for KS within 30 days. Local or topical therapy for KS indicative lesions within 60 days. Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug. Required: Approved antiretroviral therapy.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002188

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Anderson Clinical Research

Collaborators

Ligand Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00002188

Brief Title

A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

Official Title

Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.

Study Type

Interventional

2. Study Status

Record Verification Date

August 1997

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

Anderson Clinical Research

Collaborators

Ligand Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).

Detailed Description

Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active. Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Kaposi, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Antineoplastic Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

27 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alitretinoin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria Patients must have: HIV positive status and histologic confirmation of KS. CD4 count > 200 mm3 (required of one-half of patients). Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions. Acceptable organ system function. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. Prior Medication: Excluded: Systemic therapy for KS within 30 days. Local or topical therapy for KS indicative lesions within 60 days. Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug. Required: Approved antiretroviral therapy.

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

Learn more about this trial