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

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.