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

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ClinicalTrials.gov Identifier: NCT00002188
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: Alitretinoin Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

More Information

ClinicalTrials.gov Identifier: NCT00002188     History of Changes
Other Study ID Numbers: 271A
L1057-28
96ACR-LIG2
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Sarcoma, Kaposi
Antineoplastic Agents

Additional relevant MeSH terms:
HIV Infections
Sarcoma
Sarcoma, Kaposi
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Alitretinoin
Antineoplastic Agents