Kidney Cancer Clinical Trial
Official title:
A Phase I Study Of Peginterferon Alfa-2b (PEG-INTRON) With Sorafenib (Nexavar) In Patients With Unresectable Or Metastatic Clear Cell Renal Carcinoma (RCC).
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib
may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving
PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon
alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and toxicity of PEG-interferon alfa-2b and
sorafenib tosylate in patients with unresectable or metastatic clear cell renal cell
carcinoma.
Secondary
- To determine the progression-free survival of patients treated with this regimen.
- To evaluate, in a preliminary manner, the response rate and overall survival of
patients treated with this regimen.
- To evaluate the activation of interferon-induced transcription factors in immune cell
subsets (including regulatory T cells [T regs]) using a novel flow cytometric assay and
correlate this information with clinical outcome.
- To measure circulating levels of IFN-γ and IL-5 for determination of Th1/Th2 status and
CD4+, CD25+, and FoxP3 cell number (T regs) in peripheral blood.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, 22, 29,
36, 43, and 50. Patients also receive oral sorafenib tosylate 2-3 times daily on days 15-56
of course 1 and on days 1-56 of all subsequent courses. Courses repeat every 56 days for up
to 1 year in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for correlative
laboratory studies. Peripheral blood mononuclear cells are analyzed for STAT proteins
(STAT1, STAT2, STAT3, STAT4, STAT5) and CD4+, CD25+, and FoxP3 regulatory T cells by flow
cytometric assays. Samples are also analyzed for the presence of VEGF, VEGFR, IFN-γ, and
IL-5 by ELISA assays; baseline expression of Jak-STAT signaling intermediates (Jak1, Tyk2,
IFNAR, and IRF9) by immunoblot analysis; and interferon-stimulated gene expression by real
time PCR and RT-PCR analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4
months for 1 year, every 6 months for 2 years, and then annually thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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