Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

NCT02615106 | Unknown Phase 2

• 1 other identifier: SanghaiXinhua-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma

Keywords

Radiation Therapy; Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Endostar Combined With Radiotherapy

EXPERIMENTAL

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

Interventions

Endostar DRUG

7.5 mg/m2/day, day 1-14

Also known as: recombinant human endostatin

Endostar Combined With Radiotherapy

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

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

Endostar Combined With Radiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Interventions

endostar protein; Endostatins

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• mawei jiang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chuanying zhu, MD

CONTACT

862125076994; sdnanhai123@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CN (1)