What side effects are associated with this type of intervention?

Common treatments for tumors, such as chemotherapy and radiation therapy, are associated with a range of side effects. Chemotherapy drugs like paclitaxel and cyclophosphamide can cause neuropathy, cardiotoxicity, infertility, and increased risk of secondary cancers. Radiation therapy, particularly cranial radiation, can lead to neurocognitive decline, especially in younger children. Other side effects include alopecia, fatigue, depression, and anxiety. Specific drugs may also cause hematologic toxicities, such as neutropenia and anemia, as well as gastrointestinal issues like constipation and vomiting.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of tumors, including pharmacologic inhibitors and CAR T-cell therapies. For instance, pembrolizumab and nivolumab are immune checkpoint inhibitors targeting PD-1, approved for various cancers. CAR T-cell therapies like tisagenlecleucel and axicabtagene ciloleucel have been approved for certain hematologic malignancies. Additionally, temozolomide, an oral alkylating agent, is approved for glioblastoma. Investigational compounds like ONC201, which targets mitochondrial metabolism and stress response pathways, are under active investigation for gliomas. These approvals reflect a broad range of mechanisms aimed at targeting tumor growth and progression.

What other types of research exist?

Promising novel alternatives for tumor patients considering treatment in 2024 include: <ol> <li>Alectinib: Effective for central nervous system responses in ALK-positive non-small cell lung cancer.</li> <li>Crizotinib: Shows efficacy in ROS1-positive advanced non-small-cell lung cancer.</li> <li>Entrectinib: Demonstrated safety and efficacy in ROS1 fusion-positive non-small-cell lung cancer.</li> <li>Lorlatinib: Effective in advanced ROS1-positive non-small-cell lung cancer.</li> <li>Nivolumab and Ipilimumab: Combination immunotherapy showing complete response in hereditary leiomyomatosis and renal cell cancer.</li> <li>Pembrolizumab: Used in combination with chemotherapy for metastatic non-squamous non-small-cell lung cancer.</li> <li>Cabozantinib: An oral tyrosine kinase inhibitor effective in medullary thyroid cancer.</li> <li>Talazoparib: A PARP inhibitor showing promise in germline BRCA1/2-mutated HER2-negative advanced breast cancer.</li> </ol>

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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

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

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

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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.