Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma

November 6, 2022 updated by: Yang Li

Clinical Research on Efficacy and Safety of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma：A Prospective，Single-arm, Open-label, Multi-center Study

This clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide for stage 4/M neuroblastoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, single-arm, open-lable, multi-center clinical trial. Children≤ 14 years old are eligible for this study if they were newly diagnosed with neuroblastoma and assessed as stage 4 according to the International Neuroblastoma Staging System (INSS) or stage M according to the International Neuroblastoma Risk Group (INRG) respectively. Patients enrolled in this study will receive combined induction chemotherapy with arsenic trioxide following an modifed protocol based on N7 and NB2004 protocols. Objective response rate (ORR) at 4 weeks after completing induction chemotherapy was defined as the main outcome and adverse events were monitored and graded in the meantime.

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System（INSS) or the International Neuroblastoma Risk Group (INRG) staging system;
  2. Patients not more than 14 years old;
  3. There are measurable lesions;
  4. Guardians agreed and signed informed consent.

Exclusion Criteria:

  1. Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy.
  2. Patients with one or more critical organs failure such as heart, brain, kidney failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ATO-combined chemotherapy
Patients receive combined induction chemotherapy with arsenic trioxide.
Drug: Arsenic Trioxide
Arsenic trioxide（ATO） is administered 0.16mg/kg per day over eight hours IV daily for ten days. Patients will receive ATO alone on days 1-2 and combined with conventional induction chemotherapy on days 3-10. Nine cycles at most of ATO-combined chemotherapy were applied in the whole scheme.
Other Names:
  • ATO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: Four weeks after ATO-combined induction chemotherapy
Four weeks after ATO-combined induction chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of patients enrolled until the date of death from any cause，From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Survival time from patients diagnosed with stage 4/M neuroblastoma untill death
From the date of patients enrolled until the date of death from any cause，From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Progression free survival
Time Frame: From the date of patients enrolled to the date of of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Survival time from patients diagnosed with stage 4/M neuroblastoma untill disease progression or death
From the date of patients enrolled to the date of of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Incidence of adverse events
Time Frame: From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years.
Adverse events are monitored and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yang Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

December 30, 2028

Study Completion (ANTICIPATED)

December 30, 2028

Study Registration Dates

First Submitted

January 21, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (ACTUAL)

April 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYS-C-202007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroblastoma

Clinical Trials on Arsenic Trioxide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe