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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alitretinoin
Sponsored by
Anderson Clinical Research
About
Eligibility
Locations
Outcomes
Full info

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

    First Posted
    November 2, 1999
    Last Updated
    June 23, 2005
    Sponsor
    Anderson Clinical Research
    Collaborators
    Ligand Pharmaceuticals
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    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
    undefined (undefined)

    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.

    12. IPD Sharing Statement

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

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