Study on Sintilimab in Stage IV High Risk Neuroblastoma

Early Phase 1

• Conditions: Recurrent Stage IV High Risk Neuroblastoma
• Interventions: Drug: Sintilimab

• Registration Number: NCT04412408
• Lead Sponsor: Shanghai Children's Medical Center

Brief Summary

A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-08
• Last Update Posted: 2020-08-11
• Study Start: 2020-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 12 Months to 12 years
2. Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy
3. Fully recovered from the acute toxic effects of all prior anti-cancer treatment
4. At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
5. At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
6. At least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
7. Blood counts recovery including White cell count >= 750/mm^3 and Platelet count >= 50,000/mm^3
8. Creatinine clearance ≥ 50ml/min
9. Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate aminotransferase ≤ 2.5 U/dl (or < 5 in case of liver impairment)
10. Life expectancy of at least 4 months
11. Negative pregnancy test in women of childbearing potential
12. Use of an effective contraceptive method during the whole treatment and
13. up to 3 months after the completion of treatment in males and females
14. Prior informed consent signed

Exclusion Criteria

1. Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
2. Patients who are currently receiving another investigational drug are not eligible
3. Patients who are currently receiving other anti-cancer agents are not eligible
4. 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
5. 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
6. Patients who have an uncontrolled infection are not eligible.
7. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sintilimab	Sintilimab	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 Measures

Name	Time	Method
response	2 years after taking the drug	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

Name	Time	Method
side effect	2 years after taking the drug	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China