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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002212
• Other study ID #: 287A
• Secondary ID: L1069-21
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Bexarotene

Locations

Country	Name	City	State
United States	Milton S Hershey Med Ctr	Hershey	Pennsylvania
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	Desert Univ School of Medicine	Palm Springs	California

Sponsors (1)

Lead Sponsor	Collaborator
Ligand Pharmaceuticals

Country where clinical trial is conducted

United States,