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

Primary Purpose

Osteosarcoma

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

neoadjuvant chemotherapy+SPIONs/SMF

neoadjuvant chemotherapy

About this trial

This is an interventional treatment trial for Osteosarcoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

neoadjuvant chemotherapy+SPIONs/SMF

neoadjuvant chemotherapy

Outcomes

Primary Outcome Measures

Determination of the Recommended Dose

Determination of dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) (if possible), and recommended Phase 2 doses (RP2Ds)

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT04316091

First Posted

March 16, 2020

Last Updated

March 19, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Leiden University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04316091

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Leiden University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

neoadjuvant chemotherapy+SPIONs/SMF

Arm Title

Control group

Arm Type

Sham Comparator

Arm Description

neoadjuvant chemotherapy

Intervention Type

Drug

Intervention Name(s)

neoadjuvant chemotherapy+SPIONs/SMF

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

neoadjuvant chemotherapy

Intervention Description

Conventional neoadjuvant chemotherapy only

Primary Outcome Measure Information:

Title

Determination of the Recommended Dose

Description

Determination of dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) (if possible), and recommended Phase 2 doses (RP2Ds)

Time Frame

36 Months

Secondary Outcome Measure Information:

Title

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

Description

Evaluation of the Objective Response Rate: complete or partial response, as defined by RECIST 1.1

Time Frame

36 Months

Title

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

Description

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

Time Frame

36 Months

Title

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

Description

Evaluation of the time-course dependent accumulation (μg/dL) of iron in blood and urine following SPIONs intratumoral injection

Time Frame

36 Months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

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

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