Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

June 12, 2016 updated by: Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Phase 2 Study of Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. So investigators design Radiotherapy plus Endostar to treat Pediatric Neuroblastoma to research the RR and safety. Investigators believe this treatment regimen may be a new approach to the pediatric neuroblastoma patients.

Study Type

Interventional

Enrollment (Anticipated)

60

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
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Mawei Jiang, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites.
  • Life expectancy of greater than 12 months.
  • ECOG performance status ≤2
  • Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
  • Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
  • Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.

Exclusion Criteria:

  • Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered.
  • Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endostar Combined With Radiotherapy
Drug: Endostar Endostar 7.5 mg/m2/day, day 1-14 Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
Drug: Endostar
7.5 mg/m2/day, day 1-14
Other Names:
  • recombinant human endostatin
Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: first analysis will occur 1 month after accrual of all patients
first analysis will occur 1 month after accrual of all patients

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival(PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival (OS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Objective response rate (ORR)
Time Frame: first analysis will occur 1 month after accrual of all patients
first analysis will occur 1 month after accrual of all patients

Collaborators and Investigators

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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: mawei jiang, MD, The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

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

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

November 22, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 12, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SanghaiXinhua-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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