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

Primary Purpose

Childhood Brain Stem Neoplasm

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

Temozolomide

About this trial

This is an interventional treatment trial for Childhood Brain Stem Neoplasm focused on measuring Radiation Therapy, Brainstem Tumor in Children

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

he 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

radio-chemotherapy plus nimotuzumab

Arm Description

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.

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

NCT02672241

First Posted

January 31, 2016

Last Updated

October 14, 2018

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02672241

Brief Title

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

Official Title

Phase 2 Study of Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

August 1, 2019 (Anticipated)

Study Completion Date

August 2019 (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

Yes

5. Study Description

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.

Detailed Description

Nimotuzumab (h-R3), a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to the extracellular domain of EGFR, which blocks the binding of EGF and transforming growth factor-α to EGFR. High expression of EGFR protein in glioma has been associated with tumor progression and enhanced tumorigenicity. Several clinical trials have demonstrated the anti-tumor effects of nimotuzumab, such as head and neck cancer and esophageal cancer15. The purpose of this study was to evaluate the efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumors in children.

6. Conditions and Keywords

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

Childhood Brain Stem Neoplasm

Keywords

Radiation Therapy, Brainstem Tumor in Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radio-chemotherapy plus nimotuzumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Other Intervention Name(s)

h-R3, BIOMAb EGFR, Biocon

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

brand names Temodar and Temodal and Temcad

Intervention Description

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).

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 24 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 24 months

Title

Objective response rate (ORR)

Time Frame

first analysis will occur 1 month after accrual of all patients

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

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

he 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

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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