HIV Infection Clinical Trial
Official title:
A Phase II Study of Gamma Secretase Inhibitor PF-03084014 in Patients With AIDS-Associated Kaposi Sarcoma
This phase II trial studies the effects, good and bad, of gamma secretase inhibitor PF-03084014 and to see how well it works in treating patients with acquired immune deficiency virus (AIDS)-associated Kaposi sarcoma. Gamma secretase inhibitor PF-03084014 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may shrink the tumor.
PRIMARY OBJECTIVES:
I. Evaluate the tolerance and clinical response of Kaposi sarcoma (KS) tumors to PF-03084014
(gamma secretase inhibitor PF-03084014) with assessments of partial response (PR) and
complete response (CR).
SECONDARY OBJECTIVES:
I. Assess the effect of PF-03084014 on human immunodeficiency virus (HIV) viral load in
plasma and the effect of PF-03084014 on cluster of differentiation (CD)4+ cell number.
II. Assess the effect of PF-030840414 in peripheral blood mononuclear cells (PBMCs) and
tumors on Kaposi's sarcoma-associated herpesvirus (KSHV) latent and lytic gene expression.
III. Assess effects of PF-03084014 on activation of Notch target genes including
tumor-associated endothelial-mesenchymal transition and cell proliferation markers.
IV. Assess effects of trough PF-03084014 drug levels on clinical response and toxicity.
OUTLINE:
Patients receive gamma secretase inhibitor PF-03084014 orally (PO) twice daily (BID) on days
1-21. Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Patients with PR, CR, or stable disease (SD) at the
end of 4 courses may receive an additional 4 courses of gamma secretase inhibitor
PF-03084014 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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