Treatment for children with relapsed soft tissue sarcoma using a new drug combination
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.
This study is testing a new combination of drugs to see if it works better than another treatment for children aged 2 to 21 with relapsed soft tissue sarcoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 2 Years to 21 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06514313 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 21 years with relapsed or refractory soft tissue sarcoma who meet specific health criteria.
Not a fit: Patients with soft tissue sarcoma who have not progressed after first-line treatment or those with severe cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for children suffering from relapsed and refractory soft tissue sarcoma.
How similar studies have performed: Other studies have explored similar drug combinations in pediatric oncology, showing varying degrees of success, but this specific combination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.