Carcinoma, Renal Cell Clinical Trial
Official title:
A Dose-Ranging, Phase II, Open Label Study of ATN 161 in Advanced Renal Cell Cancer
The purpose of this study is to determine an active dose of ATN-161 for future studies while establishing preliminary evidence of effectiveness in patients with renal cell cancer.
Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a
requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is
a malignancy characterized by abundant vascularization and a high degree of resistance to
chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This
concept has been established by the initial successes observed in recent studies of
antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as
a therapeutic agent in CCRCC because it binds to several fully activated integrins, which
are essential downstream components in the angiogenic signaling cascade.
Functional imaging using dceMRI has been demonstrated as an effective way to show effects on
the vasculature across different tumors, including CCRCC. Preclinical experiments have shown
that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in
this study is expected to be an effective method for evaluating the antiangiogenic response
to ATN-161.
Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at
1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of
disease, unacceptable drug toxicity, or withdrawal of consent occurs.
Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again
during the second week of treatment, and finally during the fourth week of treatment.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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