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

Inclusion 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.