Clinical trial NCT00002212: A Study of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
Official title: Phase II Evaluation of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Anticarcinogenic Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Desert Univ School of Medicine
state: California
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Hershey
country: United States
facility: Milton S Hershey Med Ctr
state: Pennsylvania
Study officials:
References: