Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma

Status Completed

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of lenalidomide and to see how well it works in treating patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma (KS). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of single agent lenalidomide in subjects with AIDS-related KS. (Phase I) II. Evaluate the overall clinical response of KS tumors to lenalidomide with subset assessments of partial response (PR) and complete response (CR). (Phase II) SECONDARY OBJECTIVES: I. Evaluate the effect of lenalidomide on human immunodeficiency virus (HIV) plasma viral loads. II. Determine the effects of lenalidomide on T-lymphocyte subsets, including natural killer (NK) cells. III. Evaluation of time to response, time to relapse, and time to death amongst subjects receiving lenalidomide. IV. Determine the effect of lenalidomide on human herpesvirus (HHV)-8. V. Assess lenalidomide effects on HHV-8 copy number in peripheral blood mononuclear cell (PBMC), and plasma and whether changes in viral copy number measured in PBMC or plasma are associated with clinical response of KS tumors. VI. Monitor HHV-8 gene expression in KS biopsy specimens and PBMC pre- and post-lenalidomide and assess whether changes in viral gene expression in tumor biopsy are associated with clinical response. VII. Assess whether changes in viral copy number in the compartments assayed occur in concert or independently with changes in viral antigen expression in biopsy specimens. VIII. Assess effects of lenalidomide on growth factors relevant to tumor proliferation (i.e., interleukin [IL]-1beta, IL-2, IL-4, IL-5, IL-6, IL-10, IL-15, IL-12p70, tumour necrosis factor [TNF]alpha, and interferon gamma [IFN]gamma). IX. Characterize the effects of lenalidomide on viral and cellular gene in KS tumor biopsies. X. Assess changes in NK cell number (PBMC and tumor) and function pre- and post-lenalidomide. XI. Assess the sensitivity and specificity of dermal adhesive strip samples to detect KS and the effects of lenalidomide on the lesions. OUTLINE: This is a multicenter study. This is a phase I, dose-escalation study of lenalidomide followed by a phase II study. Patients receive lenalidomide orally (PO) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01057121
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 27, 2010
Completion date	August 4, 2014

View Details

See also
Status	Clinical Trial	Phase
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Withdrawn	`NCT02137564` - Gamma Secretase Inhibitor PF-03084014 in Treating Patients With AIDS-Associated Kaposi Sarcoma	Phase 2
Completed	`NCT01016730` - Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma	Phase 1
Withdrawn	`NCT00521092` - Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.