- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002188
A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma
Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 271A
- L1057-28
- 96ACR-LIG2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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