A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	Anderson Clinical Research Ligand Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002188

Purpose

The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).

Condition	Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: Alitretinoin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.

Resource links provided by NLM:

MedlinePlus related topics: AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: 9-cis-Retinoic acid

U.S. FDA Resources

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

Estimated Enrollment:

Detailed Description:

Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active.

Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV positive status and histologic confirmation of KS.
CD4 count > 200 mm3 (required of one-half of patients).
Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.
Acceptable organ system function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.

Prior Medication:

Excluded:

Systemic therapy for KS within 30 days.
Local or topical therapy for KS indicative lesions within 60 days.
Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.

Required:

Approved antiretroviral therapy.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	271A, L1057-28, 96ACR-LIG2
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002188 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Sarcoma, Kaposi
Antineoplastic Agents

Study placed in the following topic categories:

Opportunistic Infections
Sexually Transmitted Diseases, Viral
Alitretinoin
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Immunologic Deficiency Syndromes
Kaposi Sarcoma
Herpesviridae Infections
Virus Diseases

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Neoplasms by Histologic Type
Slow Virus Diseases
Alitretinoin
Immune System Diseases
Antineoplastic Agents
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes

Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Neoplasms, Vascular Tissue
Sarcoma
Lentivirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009