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RecruitingInterventionalPhase 2

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

NCT ID: NCT05999994Sponsor: Eli Lilly and CompanyLast updated: 2026-03-27

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.

Arms & interventions

  • DrugRamucirumab

    Administered IV

  • DrugCyclophosphamide

    Administered orally

  • DrugVinorelbine

    Administered IV

  • DrugGemcitabine

    Administered IV

  • DrugDocetaxel

    Administered IV

  • DrugAbemaciclib

    Administered orally

  • DrugIrinotecan

    Administered IV

  • DrugTemozolomide

    Administered orally

Outcome measures

Primary

  • Number of Participants Allocated to Each ISA

    Number of Participants Allocated to Each ISA

    Time frame: Baseline up to Week 4

Eligibility criteria

Sex: AllAge: 1 Year to 39 YearsHealthy volunteers: No
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.

Study locations (30)

Childrens Hospital of Alabama

Birmingham, Alabama, 35233

Not Yet Recruiting
Gregory Friedman · Principal Investigator

Phoenix Children's Hospital

Phoenix, Arizona, 85016

Recruiting
· Contact
Alok Kothari · Principal Investigator

Phoenix Children's Hospital

Phoenix, Arizona, 85016

Recruiting
Alok Kothari · Principal Investigator

Childrens Hospital of Los Angeles

Los Angeles, California, 90027

Completed

UCLA Medical Center

Los Angeles, California, 90095

Not Yet Recruiting
Noah Federman · Principal Investigator

Children's Hospital of Orange County

Orange, California, 92868

Recruiting
Josephine HaDuong · Principal Investigator

Children's Hospital of Colorado

Denver, Colorado, 80218

Recruiting
· Contact
Margaret Macy · Principal Investigator

Children's National Medical Center

Washington D.C., District of Columbia, 20010

Recruiting
· Contact
AeRang Kim · Principal Investigator

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

Recruiting
· Contact
Emad Salman · Principal Investigator

Mayo Clinic in Florida

Jacksonville, Florida, 32224

Recruiting
· Contact
Steven Attia · Principal Investigator

Children's Healthcare of Atlanta, Inc. at Egleston

Atlanta, Georgia, 30322

Not Yet Recruiting
· Contact
Thomas Cash · Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

Recruiting
· Contact
David Walterhouse · Principal Investigator

Riley Hospital for Children

Indianapolis, Indiana, 46202-5225

Active Not Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Not Yet Recruiting
· Contact
Natalie Collins · Principal Investigator

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109

Not Yet Recruiting
· Contact
Rajen Mody · Principal Investigator

University of Minnesota Hospital

Minneapolis, Minnesota, 55455

Not Yet Recruiting
· Contact
Emily Greengard · Principal Investigator

Children's Mercy Hospital

Kansas City, Missouri, 64108

Recruiting
· Contact
Kevin Ginn · Principal Investigator

Washington University Medical School

St Louis, Missouri, 63110

Completed

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
· Contact
Emily Slotkin · Principal Investigator

Nationwide Children's Hosp

Columbus, Ohio, 43205-2664

Recruiting
· Contact
Mark Ranalli · Principal Investigator

Oregon Health and Science University

Portland, Oregon, 97201

Not Yet Recruiting
· Contact
Katrina Winsnes · Principal Investigator

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Completed

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

Recruiting
Andrew Bukowinski · Principal Investigator

Lifespan Cancer Institute

Providence, Rhode Island, 02906

Recruiting
· Contact
Bradley DeNardo · Principal Investigator

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390-9063

Recruiting
Theodore Laetsch · Principal Investigator

Cook Children's Hospital

Fort Worth, Texas, 76104-2724

Active Not Recruiting

Texas Childrens Hospital

Houston, Texas, 77025

Not Yet Recruiting
· Contact
Jodi Muscal · Principal Investigator

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
· Contact
Najat Daw · Principal Investigator

Seattle Children's Hospital Research Foundation

Seattle, Washington, 98105

Recruiting
· Contact
Catherine Albert · Principal Investigator

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Not Yet Recruiting
· Contact
Meghen Browning · Principal Investigator