NCT01057121

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

A Phase I/II Study of Lenalidomide in Patients With AIDS-Associated Kaposi's Sarcoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• AIDS-Related Kaposi Sarcoma
• Recurrent Kaposi Sarcoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles. Sequential cohorts were entered at 10 mg/day, 15 mg/day, 20 mg/day and 25 mg/day using a 3+3 design to determine the MTD

Timeline

• Start date: 2010-08-27
• Primary completion: 2014-08-04
• Completion: 2014-08-04
• First posted: 2010-01-27
• Last updated: 2022-02-08
• Results posted: 2016-07-21

Locations

13 sites across 1 country: United States