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Trial Crowdsources Lung Cancer Biomarker Screening

Lung cancer X-ray

(National Cancer Institute)

22 August 2014. A clinical trial at University of Colorado Cancer Center in Aurora is recruiting participants through an online campaign to find people with lung cancer that meet a specific genetic profile who would most likely respond to the drug being tested. The study is led by Ross Camidge, director of the center’s thoracic oncology clinical program.

Camidge and colleagues are attempting to find participants for the study with locally advanced or metastatic (spreading) lung cancer and an alteration in the Fibroblast Growth Factor Receptor 1 or FGFR1 gene. Patients with either small cell or non-small cell lung cancer are eligible. When FGFR1 genes trigger an excess amount of enzymes, they can cause reactions that feed solid tumor growth, such as cell division and blood vessel development

The Colorado researchers are testing the drug ponatinib, an inhibitor of enzymes expressed by the fusion of two genes, which is found in most patients with certain types of leukemia. Ponatinib, developed and marketed by Ariad Pharmaceuticals under the brand name Iclusig, is approved by FDA to treat those leukemia cancers, but has also been shown in preclinical tests to inhibit some enzymes expressed by genes in the FGFR family.

In the Fall of 2013, Ariad heeded an FDA request to suspend sales of Iclusig while the company addressed problems of blood clotting that arose among patients taking the drug. Ariad added new label warnings and limited the use of the drug, which enabled FDA to lift the sales restrictions in January 2014.

Because of the tight eligibility restrictions of the trial, the Colorado team turned to the Internet to locate participants. The study’s Web site asks prospects to complete an online screening questionnaire about lung cancer type and progression, and other items to determine eligibility.

Patients who may fit the initial criteria are then asked to send in a tissue sample, from either an existing or repeat biopsy, for the researchers to test for FGFR1 mutations. There is no charge for the FGFR1 mutation tests, but patients who pass the screening will need to fund their own travel to Colorado for the trial.

Camidge and colleagues aim to initially recruit 110 participants for the clinical trial, but eventually hope to enroll some 700 lung cancer patients. Along the way, the researchers plan to adjust the screening criteria as they learn more about the precise kind of FGFR1 mutations that respond to ponatinib. This approach to clinical trial recruitment promises to be markedly less expensive than traditional approaches that enroll large numbers of participants at many sites in the hope of finding a sufficient number of participants meeting precise criteria to test treatments.

In addition to crowdsourcing for trial participants, the Colorado researchers are turning to crowdfunding to raise money for the trial. Camidge has raised enough money from the university and Ariad to get the study started. “However,” says Camidge in a cancer center statement, “if this trial takes off, that’s probably only about half of what we’ll need.” A campaign on the crowdfunding platform Consano aims to raise another $25,000 for the study.

In the following video, Camidge tells more about the project.

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