A Study of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
Launched by LIGAND PHARMACEUTICALS · Aug 30, 2001
Trial Information
Current as of December 06, 2024
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility 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.
About Ligand Pharmaceuticals
Ligand Pharmaceuticals is a biopharmaceutical company focused on advancing innovative therapies to address unmet medical needs across various therapeutic areas, including oncology, autoimmunity, and infectious diseases. Utilizing its proprietary technologies and a robust pipeline of drug candidates, Ligand partners with leading pharmaceutical companies to enhance drug development processes and improve patient outcomes. With a commitment to scientific excellence and collaboration, Ligand leverages its extensive expertise in drug discovery and development to deliver transformative solutions that enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
Palm Springs, California, United States
Hershey, Pennsylvania, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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