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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
No Placebo-Only Group
Summary
This trial tests new cancer drugs to see if they help patients and how long the benefits last. It focuses on different types of cancer and adds new studies as new drugs are developed.
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.
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Allocated to Each ISA
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Gemcitabine
2017
Completed Phase 3
~1920
Temozolomide
2010
Completed Phase 3
~1880
Irinotecan
2017
Completed Phase 3
~2590
Ramucirumab
2017
Completed Phase 3
~5050
Abemaciclib
2019
Completed Phase 2
~1890
Vinorelbine
2013
Completed Phase 4
~2190
Cyclophosphamide
2010
Completed Phase 4
~2310
Docetaxel
1995
Completed Phase 4
~6550
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects.
Targeted therapies interfere with specific molecules involved in tumor growth, such as tyrosine kinase inhibitors that block growth signals. Immunotherapy enhances the body's immune system to recognize and destroy cancer cells by inhibiting checkpoints that prevent immune attacks on tumors.
Understanding these mechanisms is vital for tumor patients as they offer diverse strategies to combat cancer, potentially improving outcomes and minimizing side effects.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Current trends and future directions in the genetic therapy of human neoplastic disease.
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,466,224 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