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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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).

Key facts

Study ID

NCT00002212

Run by

Ligand Pharmaceuticals

People needed

27

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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