Status:
UNKNOWN
Study on Sintilimab in Stage IV High Risk Neuroblastoma
Lead Sponsor:
Shanghai Children's Medical Center
Conditions:
Recurrent Stage IV High Risk Neuroblastoma
Eligibility:
All Genders
12-12 years
Phase:
EARLY_PHASE1
Brief Summary
A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04412408
Start Date
September 1 2020
End Date
June 30 2023
Last Update
August 11 2020
Active Locations (1)
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1
Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127