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

Study Overview
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Brief Summary
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The purpose of this study is to see if it is safe and effective to give Targretin capsules to patients with AIDS-related Kaposi's sarcoma (KS).

Detailed Description
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This is a multicenter, open-label study to evaluate the safety and efficacy of Targretin capsules in patients with AIDS-related KS. NOTE: The daily dose may be reduced as necessary for toxicity management.

Official Title
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Phase II Evaluation of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma

Conditions
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Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
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* Drug: Bexarotene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Serum HIV antibody positive by ELISA. KS documented by biopsy (repeat biopsy is not required for entry if KS has been previously confirmed histologically and the histopathology report has been reviewed). A minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions, each of which has been present for at least 30 days or has a longest dimension of at least 10mm, and has not received prior local or topical therapy within 60 days of study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Concurrent, serious, uncontrolled infection including, but not limited to: Mycobacterium avium intracellulare or other mycobacterium infection; Pneumocystis carinii pneumonia; CMV retinitis or colitis; Toxoplasma brain abscess; Cryptococcal meningitis. Serious intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. Known allergy or sensitivity to retinoid class drugs. Concurrent Medication: Excluded: Local or topical therapy such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy to any KS indicator lesion. Systemic anticancer chemotherapy, systemic anticancer hormonal therapy, and/or systemic anticancer immunotherapy. Systemic use of retinoid class drugs, beta-carotene compounds, or Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) for any indication. Human chorionic gonadotropin. Concurrent Treatment: Excluded: Radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any KS indicator lesion. Prior Medication: Excluded: Systemic treatment of KS within 30 days of study entry. Systemic treatment with either Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) or other retinoid class drugs for any indication within 30 days of study entry. Previous local or topical therapy of any KS indicator lesion such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy within 60 days of study entry. Prior Treatment: Excluded: Radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days of study entry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bexarotene|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Anticarcinogenic Agents