Back to resultsStudy on Sintilimab in Stage IV High Risk Neuroblastoma (SCMC-S-2020)
Primary Purpose
Recurrent Stage IV High Risk Neuroblastoma
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Stage IV High Risk Neuroblastoma
Eligibility Criteria
Inclusion Criteria:
- 12 Months to 12 years
- Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy
- Fully recovered from the acute toxic effects of all prior anti-cancer treatment
- At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
- At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
- At least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
- Blood counts recovery including White cell count >= 750/mm^3 and Platelet count >= 50,000/mm^3
- Creatinine clearance ≥ 50ml/min
- Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate aminotransferase ≤ 2.5 U/dl (or < 5 in case of liver impairment)
- Life expectancy of at least 4 months
- Negative pregnancy test in women of childbearing potential
- Use of an effective contraceptive method during the whole treatment and
- up to 3 months after the completion of treatment in males and females
- Prior informed consent signed
Exclusion Criteria:
- Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
- Patients who are currently receiving another investigational drug are not eligible
- Patients who are currently receiving other anti-cancer agents are not eligible
- Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
- Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
- Patients who have an uncontrolled infection are not eligible.
- Patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment
Sites / Locations
- Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sintilimab
Arm Description
Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years. Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
Outcomes
Primary Outcome Measures
response
Complete response: (CR): the tumor shrunk more than 50%.
Part of the reaction: (PR): the reduction of tumor body was more than 30%.
No response: (NP): the tumor decreased by less than 30% or increased.
Secondary Outcome Measures
side effect
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Full Information
NCT ID
NCT04412408
First Posted
May 27, 2020
Last Updated
August 8, 2020
Sponsor
Shanghai Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04412408
Brief Title
Study on Sintilimab in Stage IV High Risk Neuroblastoma
Acronym
SCMC-S-2020
Official Title
Clinical Study on the Treatment of Recurrent Stage IV High Risk Neuroblastoma With Sintilimab
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Children's Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Stage IV High Risk Neuroblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab
Arm Type
Experimental
Arm Description
Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
Dose: 2 mg / kg intravenously for 60 min (± 10 min window)
Primary Outcome Measure Information:
Title
response
Description
Complete response: (CR): the tumor shrunk more than 50%.
Part of the reaction: (PR): the reduction of tumor body was more than 30%.
No response: (NP): the tumor decreased by less than 30% or increased.
Time Frame
2 years after taking the drug
Secondary Outcome Measure Information:
Title
side effect
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
2 years after taking the drug
Other Pre-specified Outcome Measures:
Title
Mutation
Description
Mutation load, high microsatellite instability (MSI-H) or mismatch repair defect (dMMR)
Time Frame
before taking the drug
Title
programmed death-ligand1 (PD-L1) expression
Description
immunohistochemistry (IHC) test for PD-L1 and cluster of differentiation 8 (CD8) expression in tumor tissue
Time Frame
before taking the drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 Months to 12 years
Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy
Fully recovered from the acute toxic effects of all prior anti-cancer treatment
At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
At least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
Blood counts recovery including White cell count >= 750/mm^3 and Platelet count >= 50,000/mm^3
Creatinine clearance ≥ 50ml/min
Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate aminotransferase ≤ 2.5 U/dl (or < 5 in case of liver impairment)
Life expectancy of at least 4 months
Negative pregnancy test in women of childbearing potential
Use of an effective contraceptive method during the whole treatment and
up to 3 months after the completion of treatment in males and females
Prior informed consent signed
Exclusion Criteria:
Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible
Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
Patients who have an uncontrolled infection are not eligible.
Patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Gu, MD
Phone
18930830716
Email
gusong@shsmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xu, MD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Gu, Doctor
Phone
18930830716
Email
gusong@shsmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Study on Sintilimab in Stage IV High Risk Neuroblastoma
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