RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-01-22
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05999994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
  2. * The participant has a Lansky (\<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
  3. * 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.
  4. * The participant has adequate hematologic and organ function.
  5. * Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose.
  6. * 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.
  7. * 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.
  8. * Participants who have active infections requiring therapy.
  9. * Participants who have had allogeneic bone marrow or solid organ transplant.
  10. * Participants who have had, or are planning to have, certain invasive procedures.
  11. * Female participants who are pregnant or breastfeeding.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
Clinicaltrials.gov@lilly.com

Principal Investigator

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)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Childrens Hospital of Alabama
Birmingham, Alabama, 35233
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, 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
Saint 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

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-22
Study Completion Date2027-05

Study Record Updates

Study Start Date2020-01-22
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Neoplasms
  • Child
  • Adolescent