Study on Sintilimab in Stage IV High Risk Neuroblastoma

NCT04412408 | Unknown Early Phase 1

• 1 other identifier: SCMC-Sintilimab-2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Stage IV High Risk Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years after taking the drug

Secondary Outcomes (1)

• side effect

  2 years after taking the drug

Other Outcomes (2)

• Mutation

  before taking the drug

• programmed death-ligand1 (PD-L1) expression

  before taking the drug

Study Arms (1)

Sintilimab

EXPERIMENTAL

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)

Drug: Sintilimab

Interventions

Sintilimab DRUG

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)

Sintilimab

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

sintilimab

Study Officials

• Min Xu, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Gu, MD

CONTACT

18930830716; gusong@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

CN (1)