RecruitingPhase 2NCT06514313

Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.

Phase II Randomized Controlled Clinical Trial of Mitoxantrone Hydrochloride Liposome Combined With Irinotecan and Vincristine (VIM) With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.


Sponsor

Yizhuo Zhang

Enrollment

110 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.


Eligibility

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination called VIM (vinorelbine, ifosfamide, mesna) combined with VIT (an additional drug regimen) for children and young adults with soft tissue sarcomas (a type of cancer in muscles, tendons, or connective tissue) that have come back or stopped responding to prior treatment. **You may be eligible if...** - You are between 2 and 21 years old - You have been diagnosed with soft tissue sarcoma confirmed by biopsy - Your cancer has relapsed, is refractory (not responding), or has progressed after prior treatment - For rhabdomyosarcoma: you have had 1 to 3 prior lines of treatment - You have at least one measurable tumor that has not been locally treated - Your heart function is adequate (ejection fraction at least 50%) - Your physical performance score is at least 70 out of 100 **You may NOT be eligible if...** - You have fully recovered from chemotherapy toxicity from a recent treatment - You have significant heart rhythm problems or heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine

Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles.

DRUGTemozolomide+Irinotecan+Vincristine

Q3W, 4 cycles


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06514313


Related Trials