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).

Condition	Treatment or Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: Bexarotene	Phase II

Further Study Details: 

Expected Total Enrollment:  27

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

California
      Desert Univ School of Medicine, Palm Springs,  California,  92262,  United States
Louisiana
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States
Pennsylvania
      Milton S Hershey Med Ctr, Hershey,  Pennsylvania,  17033,  United States

Study ID Numbers:  287A; L1069-21
Record last reviewed:  April 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002212
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08