A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Neoplasms Clinical Trial

— CAMPFIRE  

Official title:

CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999994
• Other study ID #: 17304
• Secondary ID: J1S-MC-JAAA
• Status: Recruiting
• Phase: Phase 2
• Start date: January 22, 2020
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: Clinicaltrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Adolescent
• Child
• Neoplasms

Intervention

Drug:
• Ramucirumab
Administered IV
• Cyclophosphamide
Administered orally
• Vinorelbine
Administered IV
• Gemcitabine
Administered IV
• Docetaxel
Administered IV
• Abemaciclib
Administered orally
• Irinotecan
Administered IV
• Temozolomide
Administered orally

Locations

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	C.S. Mott Children's Hospital	Ann Arbor	Michigan
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	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Allocated to Each ISA	Number of Participants Allocated to Each ISA	Baseline up to Week 4