Clinical trial NCT05999994: A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
Official title: CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neoplasms
Child
Adolescent
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Allocated to Each ISA
timeFrame: Baseline up to Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Childrens Hospital of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Denver
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta, Inc. at Egleston
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hosp
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Hospital
state: Texas
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital Research Foundation
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Westmead
country: Australia
facility: The Sydney Children's Hospitals Network
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Bruxelles
country: Belgium
facility: UCL- Saint Luc
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
state: Aquitaine
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: Paris
country: France
facility: Institut Curie
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-Württemberg
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
state: Lombardie
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
state: Torino
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
state: Veneto
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
city: Roma
country: Italy
facility: Ospedale Bambino Gesu
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
city: Kobe
country: Japan
facility: Hyogo Prefectural Kobe Children's Hospital
state: Hyogo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Prinses Maxima Centrum
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
state: Madrid, Comunidad De
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: London
country: United Kingdom
facility: University College Hospital - London
state: Greater London
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: