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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002212
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
  Purpose

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 Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Bexarotene
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 27
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002212

Locations
United States, California
Desert Univ School of Medicine
Palm Springs, California, United States, 92262
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Pennsylvania
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Ligand Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002212     History of Changes
Other Study ID Numbers: 287A, L1069-21
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Anticarcinogenic Agents

Additional relevant MeSH terms:
Sarcoma
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on September 22, 2014