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

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.

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.