Treatment for children with relapsed soft tissue sarcoma using a new drug combination

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of a combination treatment involving mitoxantrone liposome, irinotecan, and vincristine (VIM) compared to another regimen of irinotecan, vincristine, and temozolomide (VIT) in children aged 2 to 21 with relapsed or refractory soft tissue sarcoma. Participants will be randomly assigned to one of the two treatment groups, and the outcomes will be evaluated based on their response to the therapies. The study aims to provide insights into which treatment may be more effective for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 2 years ≤age≤21 years, no gender limitation.
* The Karnofsky (≥16 years old) or Lansky (\< 16 years old) physical status score is at least 70.
* The expected survival time is not less than 12 weeks.
* Heart function: a) Cardiac COLOR ultrasound detection LVEF≥ 50%; b) ECG suggests no myocardial ischemia; c) No history of arrhythmia requiring drug intervention before enrollment.
* Pathological results for patients of soft tissue sarcoma.
* Patients with rhabdomyosarcoma are limited to first -, second -, and third-line treatment, and patients with other pathological subtypes are limited to progression, recurrence, or refractory after first-line treatment, with refractory defined as failure to achieve complete or partial response to the most recent treatment.
* Measurable lesions (according to RECIST 1.1 standards, measurable lesions have not received radiotherapy, freezing and other local treatments).
* The patient must fully recover from the acute toxic effects of all previous anticancer chemotherapy.
* Good blood and organ function.
* During study participation, patients are able to adhere to outpatient treatment, laboratory monitoring, and necessary clinical visits.
* The parent/guardian of the child or adolescent subject is capable of understanding, agreeing to, and signing the study Informed consent (ICF) and the applicable child consent form prior to initiating any program-related procedures; Subject is capable of expressing consent with parental/guardian consent (if applicable).

Exclusion Criteria:

* Once received mitoxantrone or mitoxantrone liposomes.
* Patients who had received previous VIT (irinotecan + temozolomide + vincristine) chemotherapy.
* Previous treatment with adriamycin or other anthracyclines with a total cumulative dose of adriamycin \> 360 mg/m\^2; Or patients with cardiac disease caused by previous anthracyclines.
* Receiving or not being able to discontinue P450 enzyme-induced anticonvulsant drugs (e.g., phenytoin, carbamazepine, etc.) within 4 weeks or 5 half-life periods prior to enrollment.
* Previous or concurrent clinical significance of active cardiovascular diseases.
* Severe chronic skin diseases in the past.
* Previous allergic asthma or severe allergic disease.
* Uncontrolled hypertension and diabetes.
* Have a history of other tumors, except cured cervical cancer or basal cell carcinoma of the skin.
* Active hepatitis B or hepatitis C infection.
* HIV or syphilis infected patients.
* Patients who have previously received organ transplants.
* Uncontrolled active systemic bacterial, viral, or fungal infection.
* Contraindications to high-dose hormone use, such as uncontrolled hyperglycemia, gastric ulcers, or psychiatric disorders.
* Severe neurological or psychiatric history, including epilepsy or autism.
* Pregnant, lactating women and patients of childbearing age who are unwilling to use contraception.
* Other circumstances deemed inappropriate by the investigator to participate in the study.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yizhuo Zhang, PhD
• Email: zhangyzh@sysucc.org.cn
• Phone: 020-87342460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.