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

Sponsor

Ligand Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002212

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Bexarotene	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Desert Univ School of Medicine	Palm Springs	California	United States	92262
2	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
3	Milton S Hershey Med Ctr	Hershey	Pennsylvania	United States	17033