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

Zhejiang University

Status and phase

Unknown

Phase 1

Conditions

Osteosarcoma

Treatments

Drug: neoadjuvant chemotherapy+SPIONs/SMF

Drug: neoadjuvant chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04316091

YANWQ004

Details and patient eligibility

About

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.

Full description

This study aims to evaluate the safety, efficacy, and tolerability of SPIONs/SMF in combination with neoadjuvant chemotherapy in osteosarcoma patients. They will receive intratumoral injection of SPIONs every other day for 3 times, followed by SMF for 2 hours every two days, and up to completion of 30 days, and conventional neoadjuvant chemotherapy from day 1. The sponsor hypothesizes that SPIONs/SMF will act synergistically with neoadjuvant chemotherapy to increase the cancer cell killing, to increase the local efficacy of neoadjuvant chemotherapy, and to improve the ratio of limb retention. Then, all patients will be followed every 8 weeks, for the safety evaluation and cancer disease status until the end of the study.

Enrollment

60 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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