A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
CAMPFIRE
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research
2 other identifiers
interventional
105
10 countries
73
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2020
Longer than P75 for phase_2
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2020
CompletedFirst Submitted
Initial submission to the registry
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 27, 2026
March 1, 2026
7.3 years
August 14, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Allocated to Each ISA
Number of Participants Allocated to Each ISA
Baseline up to Week 4
Study Arms (6)
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
EXPERIMENTALRamucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
Cyclophosphamide + Vinorelbine (DSRCT ISA)
ACTIVE COMPARATORCyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
EXPERIMENTALRamucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Gemcitabine + Docetaxel (SS ISA)
ACTIVE COMPARATORGemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
EXPERIMENTALAbemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Irinotecan + Temozolomide (ES ISA)
ACTIVE COMPARATORIrinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Interventions
Administered IV
Administered orally
Administered IV
Administered IV
Administered IV
Administered orally
Administered IV
Administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Childrens Hospital of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Childrens Hospital of Los Angeles
Los Angeles, California, 90027, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Children's Hospital of Colorado
Denver, Colorado, 80218, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Children's Healthcare of Atlanta, Inc. at Egleston
Atlanta, Georgia, 30322, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202-5225, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of Minnesota Hospital
Minneapolis, Minnesota, 55455, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Nationwide Children's Hosp
Columbus, Ohio, 43205-2664, United States
Oregon Health and Science University
Portland, Oregon, 97201, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Lifespan Cancer Institute
Providence, Rhode Island, 02906, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9063, United States
Cook Children's Hospital
Fort Worth, Texas, 76104-2724, United States
Texas Childrens Hospital
Houston, Texas, 77025, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Chris O'Brien Lifehouse
Camperdown, 2050, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Royal Children's Hospital
Melbourne, 3052, Australia
The Sydney Children's Hospitals Network
Westmead, 2145, Australia
UCL- Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076, France
Centre Leon Berard
Lyon, 69008, France
Centre Leon Berard
Lyon, 69008, France
Institut Curie
Paris, 75248, France
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20251, Germany
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, 10060, Italy
Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Di Padova
Padua, 35128, Italy
Ospedale Bambino Gesu
Roma, 00165, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
National Cancer Center Hospital
Chūōku, 104-0045, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hyogo Prefectural Kobe Children's Hospital
Kobe, 650-0047, Japan
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Prinses Maxima Centrum
Utrecht, 3584 CS, Netherlands
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 8035, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 8950, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, 28009, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
University College Hospital - London
London, NW1 2PG, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Royal Manchester Children's Hospital
Manchester, M13 9WL, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 14, 2023
First Posted
August 21, 2023
Study Start
January 22, 2020
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.