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

NCT ID: NCT02672241

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-08-31

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.

Conditions

Childhood Brain Stem Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radio-chemotherapy plus nimotuzumab

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.

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: 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.

Temozolomide

Intervention Type: 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).

Interventions

Nimotuzumab

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

Temozolomide

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).

Intervention Type: DRUG

Other Intervention Names

h-R3, BIOMAb EGFR, Biocon; brand names Temodar and Temodal and Temcad

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chuanying Zhu

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mawei jiang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

chuanying zhu, MD

Role: CONTACT

sdnanhai123@163.com

862125076994

Facility Contacts

chuanying zhu, MD

Role: primary

sdnanhai123@163.com

862125076994

Other Identifiers

sanghaixinhua-002

Identifier Type: -

Identifier Source: org_study_id