A Phase I/II Study of Lenalidomide in Patients With AIDS-Associated Kaposi's Sarcoma
I. Determine the 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 PR and CR. (Phase II)
I. Evaluate the effect of lenalidomide on HIV plasma viral loads. II. Determine the effects
of lenalidomide on T-lymphocyte subsets, including NK cells.
III. Evaluation of time to response, time to relapse, and time to death amongst subjects
IV. Determine the effect of lenalidomide on HHV-8. V. Assess lenalidomide effects on HHV-8
copy number in 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
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., IL-1beta, IL-2, IL-4, IL-5, IL-6, IL-10, IL-15, IL-12p70, TNFalpha, and IFNgamma).
IX. Characterize the effects of lenalidomide on viral and cellular gene in KS tumor
X. Assess changes in NK cell number (PBMC and tumor) and function pre- and
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.
Patients receive oral lenalidomide 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience DLT with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I)
Graded according to the NCI CTCAE.
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
|AIDS - Associated Malignancies Clinical Trials Consortium||Rockville, Maryland 20850|