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Trial record 5 of 531 for:    "Neuroblastoma"

Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

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ClinicalTrials.gov Identifier: NCT02615106
Recruitment Status : Unknown
Verified June 2016 by Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : November 25, 2015
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

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 Name: 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




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. Objective response rate (ORR) [ Time Frame: first analysis will occur 1 month after accrual of all patients ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615106


Contacts
Contact: chuanying zhu, MD 862125076994 sdnanhai123@163.com

Locations
China, Shanghai
The Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Chuanying zhu, MD    862125076994    sdnanhai123@163.com   
Principal Investigator: Mawei Jiang, MD         
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

Responsible Party: Chuanying Zhu, doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02615106     History of Changes
Other Study ID Numbers: SanghaiXinhua-001
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Radiation Therapy
Neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
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
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors