A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Osteosarcoma is the most common primary malignant bone tumor that mainly occurs in children and adolescents. Combined surgical resection and intensive chemotherapy has improved the 5-year overall survival rate (from 51 to 75%). However, drug-induced side effects and tumor recurrence after surgery reduce patient quality of life and cut down the patient survival rate. Superparamagnetic Iron Oxide Nanoparticles (SPIONs)/Spinning Magnetic Field (SMF) and neoadjuvant chemotherapy may increase the cancer cell killing and complete tumor shrinkage preserving local structures and functions of patients who cannot receive limb retention treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborator: Leiden University Medical Center

Criteria

Inclusion Criteria:

• Signed informed consent form

• Biopsy-confirmed cancer diagnosis

• Has at least one tumor lesion that can be accurately measured according to RECIST 1.1. and is amenable for intratumoral injection

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy >12 weeks

• Karnofsky performance status (KPS) ≥ 70

• Adequate function of organs and bone marrow

• Negative pregnancy test ≤ 7 days prior to SPIONs injection

Exclusion Criteria:

• Symptomatic central nervous system metastases and/or carcinomatous meningitis

• Known HIV or active hepatitis B/C infection

• Active infection requiring systemic treatment

• Received a live virus vaccine within 30 days prior to study treatment

• History of pneumonitis that required steroids or with current pneumonitis

• Has received prior systemic anti-neoplastic therapy, within 4 weeks prior to SPIONs injection

• Clinically significant cardiac arrhythmias

• Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system < 6 months prior to screening

• A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

• Any condition for which participation would not be in the best interest of the participant

• Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements

• Patients participating in another clinical investigation at the time of signature of the informed consent