OsteosarcomaPhase 1NCT04316091
A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma
A Phase 1 study testing neoadjuvant chemotherapy+SPIONs/SMF and neoadjuvant chemotherapy in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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%). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- neoadjuvant chemotherapy+SPIONs/SMF and neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without Superparamagnetic Iron Oxide Nanoparticles and Spinning Magnetic Field for Patients With Osteosarcoma
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.
Read the 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.
- Conditions
- Osteosarcoma
- Being tested
- neoadjuvant chemotherapy+SPIONs/SMF, neoadjuvant chemotherapy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapy+SPIONs/SMFDrug
Intratumoral injection of SPIONs, followed by SMF, combined with conventional neoadjuvant chemotherapy
neoadjuvant chemotherapyDrug
Conventional neoadjuvant chemotherapy only
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | neoadjuvant chemotherapy+SPIONs/SMF Receives: Drug: neoadjuvant chemotherapy+SPIONs/SMF |
| Control group | Sham comparator | neoadjuvant chemotherapy Receives: Drug: neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Recommended Dose
Determination of dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) (if possible), and recommended Phase 2 doses (RP2Ds)
Measured: 36 Months
Secondary outcomes (3)
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
Measured: 36 Months
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
Measured: 36 Months
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
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316091
- Sponsor's protocol ID
- YANWQ004
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without Superparamagnetic Iron Oxide Nanoparticles and Spinning Magnetic Field for Patients With Osteosarcoma
- ClinicalTrials.gov ID
- NCT04316091
- Acronym / sponsor ID
- YANWQ004
- Conditions
- Osteosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: neoadjuvant chemotherapy+SPIONs/SMFneoadjuvant chemotherapy+SPIONs/SMF |
| Control group | Sham comparator | Drug: neoadjuvant chemotherapyneoadjuvant chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemotherapy+SPIONs/SMFIntratumoral injection of SPIONs, followed by SMF, combined with conventional neoadjuvant chemotherapy | Drug | Experimental group |
| neoadjuvant chemotherapyConventional neoadjuvant chemotherapy only | Drug | Control group |
Primary outcome
Determination of the Recommended Dose
Time frame: 36 Months
Determination of dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) (if possible), and recommended Phase 2 doses (RP2Ds)
3 secondary outcomes
Evaluation of the anti-tumor response of neoadjuvant chemotherapy±SPIONs/SMF
Time frame: 36 Months
Assessment of the safety and feasibility of neoadjuvant chemotherapy±SPIONs/SMF
Time frame: 36 Months
Evaluation of the body kinetic profile of intratumorally injected neoadjuvant chemotherapy±SPIONs/SMF
Time frame: 36 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing neoadjuvant chemotherapy+SPIONs/SMF and neoadjuvant chemotherapy in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the Recommended Dose (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.