Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02615106

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: Endostar Radiation: 21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2017

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [first analysis will occur 1 month after accrual of all patients]

Secondary Outcome Measures

Progression free survival(PFS) [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) [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) [first analysis will occur 1 month after accrual of all patients]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200092

Sponsors and Collaborators

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