A Study of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
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).
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||Phase II Evaluation of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
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 older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
- 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 lesion.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002212
|Desert Univ School of Medicine
|Palm Springs, California, United States, 92262 |
|Tulane Univ School of Medicine
|New Orleans, Louisiana, United States, 70112 |
|Milton S Hershey Med Ctr
|Hershey, Pennsylvania, United States, 17033 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Acquired Immunodeficiency Syndrome
AIDS-Related Opportunistic Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Physiological Effects of Drugs