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

This study has been completed.

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

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

Drug Information available for:   9-cis-Retinoic acid   

U.S. FDA Resources

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

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

Estimated Enrollment:   27

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


Study ID Numbers:   271A, L1057-28, 96ACR-LIG2
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002188
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
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Vascular Tissue
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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