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CDK4/6 Inhibitor

Multiple Drug Therapies for Cancer in Children and Young Adults (CAMPFIRE Trial)

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 4

Awards & highlights

CAMPFIRE Trial Summary

This trial helps research sites & sponsors run clinical trials more efficiently. It assesses drug/disease-specific goals and activities, with new studies added as new drugs emerge. Participation depends on the benefit's duration.

Who is the study for?

This trial is for children and young adults with cancer who have a performance score of at least 50, measurable disease, and adequate organ function. They must not have received cancer treatment or investigational agents in the last 7 days. Participants must agree to use effective contraception.Check my eligibility

What is being tested?

The master protocol oversees multiple trials testing drugs like Cyclophosphamide, Gemcitabine, and others against various cancers in youths. It aims to streamline research by using a common framework that adapts as new treatments are introduced.See study design

What are the potential side effects?

Potential side effects include those typical of chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to lowered blood counts, and possible damage to organs from drug toxicity.

CAMPFIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Allocated to Each ISA

CAMPFIRE Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)Experimental Treatment3 Interventions

Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.

Group II: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)Experimental Treatment3 Interventions

Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).

Group III: Abemaciclib + Irinotecan + Temozolomide (ES ISA)Experimental Treatment3 Interventions

Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.

Group IV: Cyclophosphamide + Vinorelbine (DSRCT ISA)Active Control2 Interventions

Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.

Group V: Gemcitabine + Docetaxel (SS ISA)Active Control2 Interventions

Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.

Group VI: Irinotecan + Temozolomide (ES ISA)Active Control2 Interventions

Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vinorelbine

2013

Completed Phase 4

~2190

Cyclophosphamide

1995

Completed Phase 3

~3770

Irinotecan

2017

Completed Phase 4

~2680

Temozolomide

2010

Completed Phase 3

~1930

Abemaciclib

2019

Completed Phase 2

~1710

Ramucirumab

2017

Completed Phase 3

~5050

Gemcitabine

2017

Completed Phase 3

~2070

Docetaxel

1995

Completed Phase 4

~5620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,494 Total Patients Enrolled

3 Trials studying Tumors

1,585 Patients Enrolled for Tumors

Study DirectorEli Lilly and Company

1 Previous Clinical Trials

45 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 55 and over eligible to join this trial?

"As specified in the eligibility requirements, this medical trial targets individuals aged 1 to 39 years old. Concurrently, 383 studies are dedicated to minors and 2361 focused on patients over 65."

Answered by AI

What is the current participation rate among potential participants in this trial?

"This trial requires a total of 105 participants who meet the pre-established admission criteria. Participants can receive treatment at Childrens Hospital of Alabama in Birmingham, Arizona and Phoenix Children's Hospital in Phoenix, California among other locations."

Answered by AI

How extensive is the geographic span of this research project?

"58 medical facilities are enrolling participants for this trial, including Childrens Hospital of Alabama in Birmingham, Phoenix Children's Hospital in Phoenix and Children's Hospital of Orange County in Orange. There is also a plethora of other locations available to eligible patients."

Answered by AI

Has the DSRCT ISA combination of Ramucirumab, Cyclophosphamide and Vinorelbine earned FDA approval?

"The safety of Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) is estimated to be a 2, as it has only been tested in Phase 2 trials and there is currently no data supporting efficacy."

Answered by AI

Are there vacancies for participants in this research study?

"Confirmed. According to information provided by clinicaltrials.gov, this medical trial has been recruiting since January 22nd 2020 and is continuing to do so as of October 10th 2023. The study seeks 105 patients from 58 different sites."

Answered by AI

Could I be admitted to this clinical investigation?

"This clinical trial seeks 105 participants aged 1-39 with children who also meet the following criteria: having adequate hematologic and organ function, agreeing to use highly effective contraceptive measures during the trial and for 3 months after taking their last dose of study drug, meeting all inclusion criteria specified in protocol amendment (individual addenda), displaying measurable or evaluable disease via RECIST 1.1 techniques, possessing a Lansky/Karnofsky performance score of at least 50, ceasing previous treatments for cancer or investigational agents 7 days before first dose in this trial, passing urine/serum pregnancy test within one week prior to first dose;"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999994.

All > Cancer > Oncology