Study on Sintilimab in Stage IV High Risk Neuroblastoma

NCT ID: NCT04412408

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Song Gu, MD

Role: CONTACT

gusong@shsmu.edu.cn

18930830716

Facility Contacts

Song Gu, Doctor

Role: primary

gusong@shsmu.edu.cn

18930830716

Other Identifiers

SCMC-Sintilimab-2020

Identifier Type: -

Identifier Source: org_study_id