Summary

Eligibility
for people ages 1-39 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Noah Federman

Description

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.

Official Title

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

Keywords

Neoplasms, Child, Adolescent, Cyclophosphamide, Temozolomide, Gemcitabine, Docetaxel, Irinotecan, Vinorelbine, Ramucirumab, Abemaciclib, Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA), Cyclophosphamide + Vinorelbine (DSRCT ISA), Ramucirumab + Gemcitabine + Docetaxel (SS ISA), Gemcitabine + Docetaxel (SS ISA), Abemaciclib + Irinotecan + Temozolomide (ES ISA), Irinotecan + Temozolomide (ES ISA)

Eligibility

For people ages 1-39

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.

Locations

  • UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • Childrens Hospital of Los Angeles completed
    Los Angeles California 90027 United States
  • Children's Hospital of Orange County accepting new patients
    Orange California 92868 United States
  • Phoenix Children's Hospital accepting new patients
    Phoenix Arizona 85016 United States

Lead Scientist at UCLA

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT05999994
Phase
Phase 2 Neoplasms Research Study
Study Type
Interventional
Participants
Expecting 105 study participants
Last Updated