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

NCT04316091 | Unknown Phase 1

• 1 other identifier: YANWQ004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of the anti-tumor response of neoadjuvant chemotherapy±SPIONs/SMF

  36 Months

• Assessment of the safety and feasibility of neoadjuvant chemotherapy±SPIONs/SMF

  36 Months

• Evaluation of the body kinetic profile of intratumorally injected neoadjuvant chemotherapy±SPIONs/SMF

  36 Months

Study Arms (2)

Experimental group

EXPERIMENTAL

neoadjuvant chemotherapy+SPIONs/SMF

Drug: neoadjuvant chemotherapy+SPIONs/SMF

Control group

SHAM COMPARATOR

neoadjuvant chemotherapy

Drug: neoadjuvant chemotherapy

Interventions

neoadjuvant chemotherapy+SPIONs/SMF DRUG

Intratumoral injection of SPIONs, followed by SMF, combined with conventional neoadjuvant chemotherapy

Experimental group

neoadjuvant chemotherapy DRUG

Conventional neoadjuvant chemotherapy only

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Leiden University Medical Center: collaborator

MeSH Terms

Conditions

Osteosarcoma

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 20, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2023
• Last Updated: March 20, 2020

Record last verified: 2020-03