Neoplasms Clinical Trial
— CAMPFIREOfficial title:
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research
The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.
| Status | Recruiting |
| Enrollment | 105 |
| Est. completion date | May 1, 2026 |
| Est. primary completion date | May 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 39 Years |
| Eligibility | Inclusion Criteria: Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll. - Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). - The participant has a Lansky (<16 years of age) or Karnofsky (=16 years of age) performance score of at least 50. - Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (=)7 days after the last dose and must have recovered from clinically significant side effects. - The participant has adequate hematologic and organ function. - Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose. - Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug. Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll. - Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol. - Participants who have active infections requiring therapy. - Participants who have had allogeneic bone marrow or solid organ transplant. - Participants who have had, or are planning to have, certain invasive procedures. - Female participants who are pregnant or breastfeeding. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Chris O'Brien Lifehouse | Camperdown | New South Wales |
| Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
| Australia | Royal Children's Hospital | Melbourne | Victoria |
| Australia | The Sydney Children's Hospitals Network | Westmead | New South Wales |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| France | Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | |
| France | Centre Leon Berard | Lyon | Rhône-Alpes |
| France | Centre Leon Berard | Lyon | Rhône-Alpes |
| Germany | Universitaetsklinikum Essen | Essen | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Freiburg | Freiburg | Baden-Württemberg |
| Germany | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | |
| Italy | IRCCS Istituto Ortopedico Rizzoli | Bologna | |
| Italy | Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia | Candiolo | Torino |
| Italy | Istituto Nazionale dei Tumori | Milano | Lombardie |
| Italy | Azienda Ospedaliera Di Padova | Padova | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Roma | Lazio |
| Italy | Ospedale Bambino Gesu | Roma | |
| Italy | Istituto Clinico Humanitas | Rozzano | Milano |
| Japan | National Cancer Center Hospital | Chuo-ku | Tokyo |
| Japan | Kyushu University Hospital | Fukuoka | |
| Japan | Hyogo Prefectural Kobe Children's Hospital | Kobe | Hyogo |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Catalunya [Cataluña] |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] |
| Spain | Hospital Universitario de Canarias | La Laguna | Santa Cruz De Tenerife |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Infantil Universitario Niño Jesús | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario La Paz | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Spain | Hospital Universitari i Politecnic La Fe | València | |
| United Kingdom | Royal Marsden Hospital | London | Greater London |
| United Kingdom | University College Hospital - London | London | |
| United Kingdom | Royal Manchester Children's Hospital | Manchester | |
| United Kingdom | The Christie NHS Foundation Trust | Manchester | |
| United Kingdom | Royal Marsden Hospital | Sutton | Surrey |
| United States | Children's Healthcare of Atlanta, Inc. at Egleston | Atlanta | Georgia |
| United States | Children's Hospital of Colorado | Aurora | Colorado |
| United States | Childrens Hospital of Alabama | Birmingham | Alabama |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Nationwide Children's Hosp | Columbus | Ohio |
| United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
| United States | Cook Children's Hospital | Fort Worth | Texas |
| United States | Texas Childrens Hospital | Houston | Texas |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Riley Hospital for Children | Indianapolis | Indiana |
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | Childrens Hospital of Los Angeles | Los Angeles | California |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | University of Minnesota Hospital | Minneapolis | Minnesota |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Lifespan Cancer Institute | Providence | Rhode Island |
| United States | Washington University Medical School | Saint Louis | Missouri |
| United States | Seattle Children's Hospital Research Foundation | Seattle | Washington |
| United States | Children's National Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Australia, Belgium, France, Germany, Italy, Japan, Spain, United Kingdom,
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|---|---|---|---|---|
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