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

Osteosarcoma Clinical Trial

Official title:

A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without Superparamagnetic Iron Oxide Nanoparticles and Spinning Magnetic Field for Patients With Osteosarcoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04316091
• Other study ID #: YANWQ004
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• neoadjuvant chemotherapy+SPIONs/SMF
Intratumoral injection of SPIONs, followed by SMF, combined with conventional neoadjuvant chemotherapy
• neoadjuvant chemotherapy
Conventional neoadjuvant chemotherapy only

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the Recommended Dose	Determination of dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) (if possible), and recommended Phase 2 doses (RP2Ds)	36 Months
Secondary	Evaluation of the anti-tumor response of neoadjuvant chemotherapy±SPIONs/SMF	Evaluation of the Objective Response Rate: complete or partial response, as defined by RECIST 1.1	36 Months
Secondary	Assessment of the safety and feasibility of neoadjuvant chemotherapy±SPIONs/SMF	Assessment of the number of participants with related late onset toxicities defined as any Grade =3 adverse event (AE) occurring after the end of treatment (EOT) visit	36 Months
Secondary	Evaluation of the body kinetic profile of intratumorally injected neoadjuvant chemotherapy±SPIONs/SMF	Evaluation of the time-course dependent accumulation (µg/dL) of iron in blood and urine following SPIONs intratumoral injection	36 Months