Phase II Evaluation of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
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
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
- 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.
- 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.
Radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any KS indicator
- 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.
- Radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days
of study entry.