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

Conditions

Neoplasms, Child, Adolescent

Study Overview

Study Details

Study 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.

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

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

Condition
Neoplasms
Intervention / Treatment

-

Contacts and Locations

Birmingham

Childrens Hospital of Alabama, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Los Angeles

Childrens Hospital of Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

Denver

Children's Hospital of Colorado, Denver, Colorado, United States, 80218

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Fort Myers

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States, 33908

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Atlanta

Children's Healthcare of Atlanta, Inc. at Egleston, Atlanta, Georgia, United States, 30322

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 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.

Ages Eligible for Study

1 Year to 39 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-05