Phase I Trial: SABR and Ipilimumab—Response

Phase I Clinical Trial Design

Phase I antibody risks, trial safety examined.

Antibody therapies are the subject of discussion on both sides of the Atlantic this year. Britain and Germany are dealing with the serious fallout of a phase I trial this spring, and U.S. regulatory agencies are working to settle issues of dosing and treatment of antibody therapies in phase I trials. The phase I trial, using a drug developed by the German company TeGenero AG, is part of a new w...

Trial Bank Publishing: Phase I Results

BACKGROUND Randomized clinical trials (RCTs) are an important source of evidence for clinical practice, but finding and applying RCT reports to care is time consuming. Publishing RCTs directly into machine-understandable "trial banks" may allow computers to deliver RCT evidence more selectively and effectively to clinicians. METHODS Authors of eligible RCTs published in JAMA or the Annals of ...

A prospective phase I dose-escalation trial of stereotactic ablative radiotherapy (SABR) as an alternative to cytoreductive nephrectomy for inoperable patients with metastatic renal cell carcinoma

BACKGROUND Cytoreductive nephrectomy is thought to improve survival in metastatic renal cell carcinoma (mRCC). As many patients are ineligible for major surgery, we hypothesized that SABR could be a safe alternative. METHODS In this dose-escalation trial, inoperable mRCC patients underwent SABR targeting the entire affected kidney. Toxicity (CTCAE v3.0), quality of life (QoL), renal function,...

Phase I clinical trial combining imatinib mesylate and IL-2

We performed a Phase I clinical trial from October 2007 to October 2009, enrolling patients affected by refractory solid tumors, to determine the maximum tolerated dose (MTD) of interleukin (IL)-2 combined with low dose cyclophosphamide (CTX) and imatinib mesylate (IM). In a companion paper published in this issue of OncoImmunology, we show that the MTD of IL-2 is 6 MIU/day for 5 consecutive da...