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Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

Primary Purpose

Neuroblastoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostar

21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring Radiation Therapy, Neuroblastoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endostar Combined With Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Progression free survival(PFS)

Overall survival (OS)

Objective response rate (ORR)

Full Information

NCT ID

NCT02615106

First Posted

November 22, 2015

Last Updated

June 12, 2016

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02615106

Brief Title

Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroblastoma

Keywords

Radiation Therapy, Neuroblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endostar Combined With Radiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Endostar

Other Intervention Name(s)

recombinant human endostatin

Intervention Description

7.5 mg/m2/day, day 1-14

Intervention Type

Radiation

Intervention Name(s)

21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor

Intervention Description

21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Objective response rate (ORR)

Time Frame

first analysis will occur 1 month after accrual of all patients

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

chuanying zhu, MD

Phone

862125076994

sdnanhai123@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mawei jiang, MD

Organizational Affiliation

The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuanying zhu, MD

Phone

862125076994

sdnanhai123@163.com

First Name & Middle Initial & Last Name & Degree

Mawei Jiang, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

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