A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jan 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach using a combination of medications called liposomal mitoxantrone, capecitabine, and anlotinib to see if it can help children, adolescents, and young adults with solid tumors that have come back or have not responded to previous treatments. The main goal of the study is to find out if this treatment can improve the chances of tumor shrinkage compared to past treatments and to check for any side effects it may cause. Participants will receive this treatment for 4 to 6 cycles, with each cycle lasting 21 days, and will be closely monitored through regular check-ups and tests to evaluate how well the treatment is working and its safety.

To be eligible for this trial, participants must be between 6 and 24 years old and diagnosed with specific types of solid tumors that can be measured with imaging tests. They also need to be in good overall health, with certain blood and organ function levels. It's important that they understand the study and agree to participate. As this trial is not yet recruiting, interested families should stay tuned for updates on when they can apply.

Gender

ALL

Eligibility criteria

• Main inclusion Criteria:
• • 1. The patient fully understands this study, voluntarily participates and signs the informed consent form (ICF).
• • 2. Age: children (6 - 12 years old), adolescents (13 - 18 years old) and young adults (19 - 24 years old) (CAYA). The expected survival time is \> 3 months.
• • 3. Diagnosed with relapsed and refractory solid tumors by histopathology, and it is one of the following subtypes: (1) bone and soft tissue tumors; (2) neuroblastoma; (3) other types of solid tumors that the investigator deems eligible for enrollment.
• • 4. There must be measurable tumor lesions by CT, enhanced CT, PET/CT or MRI.
• • 5. Karnofsky score \> 50; ECOG score ≤ 2.
• • 6. Bone marrow function: neutrophil count \> 1.5 × 10⁹/L, platelet count \> 75 × 10⁹/L, hemoglobin ≥ 80 g/L.
• • 7. Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT \< 2.5 times the upper limit of normal value (for patients with liver invasion \< 5 times the upper limit of normal value); total bilirubin \< 1.5 times the upper limit of normal value (for patients with liver invasion \< 3 times the upper limit of normal value).
• • 8. No history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, no history of clinically severe pericardial disease, or no electrocardiogram evidence of acute ischemic or active conduction system abnormality within 6 months before recruitment.
• Main exclusion Criteria:
• • 1. Patients with known hypersensitivity to any component of the study drugs.
• • 2. Patients with other malignant tumors that are not under control (except for basal cell carcinoma of the skin, in-situ breast/cervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years).
• • 3. Pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures.
• • 4. Other situations judged by the investigator as not suitable for participating in this study.