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

Tracking Information
First Submitted Date ICMJE	November 2, 1999
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	June 24, 2005
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma
Official Title ICMJE	Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
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).
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Sarcoma, Kaposi; HIV Infections
Intervention ICMJE	Drug: Alitretinoin
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	27
Original Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00002188
Other Study ID Numbers ICMJE	271A; L1057-28; 96ACR-LIG2
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Anderson Clinical Research
Collaborators ICMJE	Ligand Pharmaceuticals
Investigators ICMJE	Not Provided
PRS Account	NIH AIDS Clinical Trials Information Service
Verification Date	August 1997
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP