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

Overview

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.

Interventions

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

Primary outcome measures

• Number of Participants Allocated to Each ISA [Time frame: Baseline up to Week 4]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 30 centers

• Childrens Hospital of Alabama — Birmingham
• Phoenix Children's Hospital — Phoenix
• Phoenix Children's Hospital — Phoenix
• Childrens Hospital of Los Angeles — Los Angeles
• UCLA Medical Center — Los Angeles
• Children's Hospital of Orange County — Orange
• Children's Hospital of Colorado — Denver
• Children's National Medical Center — Washington D.C.
• … and 22 more centers

Spain · 13 centers

• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Sant Joan de Déu — Esplugues de Llobregat
• Hospital General Universitario Gregorio Marañon — Madrid
• Hospital General Universitario Gregorio Marañon — Madrid
• Hospital Infantil Universitario Niño Jesús — Madrid
• Hospital Universitario La Paz — Madrid
• … and 5 more centers

Italy · 7 centers

• IRCCS Istituto Ortopedico Rizzoli — Bologna
• Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo
• Istituto Nazionale dei Tumori — Milan
• Azienda Ospedaliera Di Padova — Padova
• Ospedale Bambino Gesu — Roma
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma
• Istituto Clinico Humanitas — Rozzano

United Kingdom · 5 centers

• University College Hospital - London — London
• Royal Marsden Hospital — London
• Royal Marsden Hospital — London
• Royal Manchester Children's Hospital — Manchester
• The Christie NHS Foundation Trust — Manchester

France · 4 centers

• Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux
• Centre Leon Berard — Lyon
• Centre Leon Berard — Lyon
• Institut Curie — Paris

Australia · 3 centers

• Chris O'Brien Lifehouse — Camperdown
• Peter MacCallum Cancer Centre — Melbourne
• Royal Children's Hospital — Melbourne

Germany · 3 centers

• Universitaetsklinikum Essen — Essen
• Universitaetsklinikum Freiburg — Freiburg im Breisgau
• Universitaetsklinikum Hamburg-Eppendorf — Hamburg

Japan · 3 centers

• National Cancer Center Hospital — Chūōku
• Kyushu University Hospital — Fukuoka
• Hyogo Prefectural Kobe Children's Hospital — Kobe

Belgium · 2 centers

• UCL- Saint Luc — Brussels
• Universitair Ziekenhuis Gent — Ghent

Netherlands · 2 centers

• Leids Universitair Medisch Centrum — Leiden
• Prinses Maxima Centrum — Utrecht

Identifiers

NCT: NCT05999994 · 17304 · J1S-MC-JAAA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗