Status:
UNKNOWN
A Phase I Clinical Trial of Neoadjuvant Chemotherapy With/Without SPIONs/SMF for Patients With Osteosarcoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Osteosarcoma
Eligibility:
All Genders
Phase:
PHASE1
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 surv...
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 SPIO...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04316091
Start Date
September 1 2020
End Date
August 31 2023
Last Update
March 20 2020
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