publication date: Sep. 26, 2014


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By Paul Goldberg

NCI has launched a pilot study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies,

The Exceptional Responders Initiative seeks to identify the molecular features of tumors that predict whether a particular drug or class of drugs will be beneficial. 

The observational study would seek to recruit 300 patients, all of them at NIH. To be eligible for the study, patients must have documented exceptional response, defined by the following criteria:

• Received a treatment in which less than 10 percent of patients are expected to have a complete response, or a durable (at least 6 months) partial response; the proportion of objective responses for the trial or clinical setting in which the patient’s response was observed should be expected to be less than 10 percent (in the patient’s cancer type).

• Achieved either a) a complete response, or b) a partial response with duration at least 6 months, as defined by Response Evaluation Criteria in Solid Tumors criteria for solid tumors or response criteria for tumors where RECIST is not commonly used, when treated with the particular agent.

• Patients exceptional response was observed while enrolled on a completed clinical trial of an investigational agent, investigational combination, or standard therapy that is not considered effective for greater than 10 percent of the population with the patient’s tumor type.

• Required tumor samples must exist and be able to be submitted; investigators wishing to submit samples must not have made agreements that would prohibit this submission.

• Tumor tissue from … Continue reading 40-36 NCI Starts “Exceptional Responders” Study

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