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dc.contributorRosolowski, Tacey Ann
dc.contributor.authorKleinerman, Eugenie
dc.date.accessioned2019-09-25T22:43:16Z
dc.date.available2019-09-25T22:43:16Z
dc.date.created2018-11-05 13:00
dc.date.issuedMay 29, 2014
dc.identifieroai:cdm16333.contentdm.oclc.org:p16333coll1/1470
dc.identifierKleinerman,E_02_20140529_S09
dc.identifierhttp://cdm16333.contentdm.oclc.org/cdm/ref/collection/p16333coll1/id/1470
dc.identifier.urihttp://hdl.handle.net/20.500.12424/561053
dc.description.abstractIn this segment, Dr. Kleinerman tells the next part of the MEPACT story: designing a Phase II trial, something she had never done before. She sketches the practical elements of submitting a proposal, then explains that the protocol design she had in mind differed substantially from traditional approaches, which do not include clinical results in the original research conceptions. She explains that she was interested in designing a trial to demonstrate that MEPACT therapy works, and notes the acceptance, at the time, that 85% of osteosarcoma patients relapsed after surgery, even with “salvage chemotherapy.” In taking this approach, she notes, “I was ahead of my time.” Next Dr. Kleinerman explains how she designed the Phase II trial and the parameters she set for selection patients. She notes that her approach was new because it was based on laboratory science –and that it was controversial at the time. “I was one of the cowboys at MD Anderson.” [[CLIP Dr. Kleinerman explains that MD Anderson had a culture of using pioneering approaches to treat cancer. The attitude was, If you have a reasonable approach and are observing correct procedure to guarantee patient safety and consent, why not try? What do we currently have to treat a disease and why are we saying ‘No’?” Dr. Kleinerman says, “We do it first and we show the world.]] Dr. Kleinerman then describes the protocol and some surprising initial results that came from the Phase II trial and demonstrated the effectiveness of MEPACT on pulmonary metastases. She also talks about the accommodations she made for patients from other states who were enrolled in the clinical trial –a new MD Anderson concept at the time. She notes that the study took three years and after 20 years, 50% of the patients are still alive. She also recalls that when she presented her results at the Bone Cancer Study Group, she received a very negative reaction.
dc.format.mediumXML
dc.languageEnglish
dc.publisherHistorical Resources Center, Research Medical Library, University of Texas MD Anderson Cancer Center
dc.rightsEugenie Kleinerman, MD, Oral History Interview, May 29, 2014, Historical Resources Center, Research Medical Library, University of Texas MD Anderson Cancer Center
dc.sourceMaking Cancer History® Voices Oral History Collection
dc.subjectA: The Researcher; C: Discovery, Creativity and Innovation; C: Professional Practice; C: The Professional at Work; C: Discovery and Success; B: Institutional Mission and Values; B: MD Anderson Culture; B: Multi-disciplinary Approaches; D: Understanding Cancer, the History of Science, Cancer Research; B: MD Anderson History; B: MD Anderson Impact; C: Controversies;
dc.subjectA: The Researcher; A: The Interview Subject's Story;
dc.titleSegment 09: Designing a Phase II Trial for MEPACT, and the Characteristics of Translational Research
dc.typeInterview Segment;
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ge.dataimportlabelOAI metadata object
ge.identifier.legacyglobethics:15683805
ge.identifier.permalinkhttps://www.globethics.net/gtl/15683805
ge.lastmodificationdate2018-11-05 13:00
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ge.oai.setnameMaking Cancer History® Voices Oral History Collection
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