Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

NCT02672241 | Unknown Phase 2 DMC

• 1 other identifier: sanghaixinhua-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.

Conditions

Childhood Brain Stem Neoplasm

Keywords

Radiation Therapy; Brainstem Tumor in Children

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 24 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 24 months

• Objective response rate (ORR)

  first analysis will occur 1 month after accrual of all patients

Study Arms (1)

radio-chemotherapy plus nimotuzumab

EXPERIMENTAL

Radiotherapy: The total radiation dose is 52.2Gy (1.8Gy fractions). Chemotherapy: Nimotuzumab, given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression. Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation therapy are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles.

Drug: Nimotuzumab; Drug: Temozolomide

Interventions

Nimotuzumab DRUG

Nimotuzumab given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression.

Also known as: h-R3, BIOMAb EGFR, Biocon

radio-chemotherapy plus nimotuzumab

Temozolomide DRUG

Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).

Also known as: brand names Temodar and Temodal and Temcad

radio-chemotherapy plus nimotuzumab

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients must be \>/= 3 and \</= 21 years of age.
• Patients must have a newly diagnosed or progressive brain stem tumor.
• If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
• Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
• Cervicomedullary junction tumors are ineligible.
• Patients with a diagnosis of NF-1 are ineligible.
• Patients must be registered within 6 weeks from diagnosis or recurrence.
• Patients must have life expectancy \> 6 weeks.
• Patients must have adequate hematologic and renal function: ANC \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.).
• Written informed consent must be obtained according to institutional guidelines.

You may not qualify if:

• Cervicomedullary junction tumors are ineligible.
• Patients with a diagnosis of NF-1 are ineligible.
• Pregnant or nursing women are ineligible.
• Patients must not start treatment until informed consent is given and the patient is registered.

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Interventions

nimotuzumab; Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: January 31, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)