Study of Re-irradiation at Relapse Versus RT and Multiple Elective rt Courses

NCT03620032 | Unknown Phase 2 DMC

• 1 other identifier: 2015-002185-23
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, non-blinded, randomised two cohorts study on the efficacy of two different radiotherapy schedule for DIPG by using the same concomitant and post-radiotherapy systemic treatment.

Conditions

Diffuse Intrinsic Pontine Glioma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Primary aim of this study will be to compare the best response up to 36 weeks (CR+PR) between conventional and experimental irradiation. Such an end point was chosen since tumor reduction has been demonstrated to be correlated with better PFS and OS. The response will be evaluated according to radiological and clinical criteria. Radiological criteria will be RECIST ones.

  3 years

Secondary Outcomes (8)

• disease stabilization rate

  3 years

• PFS

  3 years

• OS

  3 years

• radiotherapy toxicity (adverse events)

  3 years

• PedsQL (Paediatric Quality of Life Questionnaire)

  3 years

Study Arms (2)

Standard treatment

OTHER

Nimotuzumab 150 mg /mq/d as iv weekly and Vinorelbine 20 mg/mq/d weekly, in week 1-12 (Induction phase).If not progression Nimotuzumab 150 mg/m2 as iv and Vinorelbine 25 mg/m²/d as iv until progression or maximum at week 108; in case of non-progressive disease re-irradiation 1 for a total of 19.8 Gy from week 26 to week 28; in case of non-progressive disease: re-irradiation 2 for a total of 19.8 Gy from week 46 to week 48. Irradiation will be scheduled to begin in the 3rd week after starting the nimotuzumab and vinorelbine treatment. For the first course, a total dose of 36 Gy will be delivered, in 1.8 Gy daily fractions 5 days a week.

Drug: Nimotuzumab; Drug: Vinorelbine; Other: Radiotherapy

Experimental treatment

EXPERIMENTAL

Nimotuzumab 150 mg /mq/d as iv weekly and Vinorelbine 20 mg/mq/d weekly, in week 1-12 (Induction phase).If not progression Nimotuzumab 150 mg/m2 as iv and Vinorelbine 25 mg/m²/d as iv until progression or maximum at week 108; in case of non-progressive disease re-irradiation 1 for a total of 19.8 Gy from week 26 to week 28; in case of non-progressive disease: re-irradiation 2 for a total of 19.8 Gy from week 46 to week 48. Irradiation will be scheduled to begin in the 3rd week after starting the nimotuzumab and vinorelbine treatment. For the first course, a total dose of 36 Gy will be delivered, in 1.8 Gy daily fractions 5 days a week.

Drug: Nimotuzumab; Drug: Vinorelbine; Other: Radiotherapy

Interventions

Nimotuzumab DRUG

humanized therapeutic monoclonal antibody against epidermal growth factor receptor (EGFR)

Also known as: humanized therapeutic monoclonal antibody

Experimental treatment; Standard treatment

Vinorelbine DRUG

Chemotherapy

Also known as: Chemotherapy

Experimental treatment; Standard treatment

Radiotherapy OTHER

RADIOTHERAPY SCHEDULE IS DESCRIBED FOR BOTH GROUPS IN THE PERAGRAPH TITLET ARMS

Experimental treatment; Standard treatment

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients from 2 to 21 years old will be eligible
• No previous treatment consented apart from steroids
• Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons)
• symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 %
• no organ dysfunction; no pregnancy or breast-feeding
• Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory
• Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment.

You may not qualify if:

• Patients below 2 years or over 21
• Pre-treatment with radio or chemotherapy
• Neurofibromatosis 1
• Non-typical imaging
• Symptoms duration over 6 months, Lansky/Karnowski scores below 40%
• Metastatic disease as shown by MRI
• Organ dysfunction, pregnancy or breast-feeding
• Absence of parents, patient or tutor consent

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• University of Roma La Sapienza: collaborator
• Johannes Gutenberg University Mainz: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Wuerzburg University Hospital: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Related Publications (53)

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• Broniscer A, Baker JN, Tagen M, Onar-Thomas A, Gilbertson RJ, Davidoff AM, Pai Panandiker AS, Leung W, Chin TK, Stewart CF, Kocak M, Rowland C, Merchant TE, Kaste SC, Gajjar A. Phase I study of vandetanib during and after radiotherapy in children with diffuse intrinsic pontine glioma. J Clin Oncol. 2010 Nov 1;28(31):4762-8. doi: 10.1200/JCO.2010.30.3545. Epub 2010 Oct 4.

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  RESULT

• Fleischhack G, Siegler N, Zimmermann M, et al. Concomitant therapy of nimotuzumab and standard radiotherapy for the treatment of newly diagnosed diffuse intrinsic pontine gliomas in children and adolescents. 14th international symposium of pediatric neuro-oncology, Vienna, Austria 20-23 June 2010

  RESULT

• Broniscer A, Baker SD, Wetmore C, Pai Panandiker AS, Huang J, Davidoff AM, Onar-Thomas A, Panetta JC, Chin TK, Merchant TE, Baker JN, Kaste SC, Gajjar A, Stewart CF. Phase I trial, pharmacokinetics, and pharmacodynamics of vandetanib and dasatinib in children with newly diagnosed diffuse intrinsic pontine glioma. Clin Cancer Res. 2013 Jun 1;19(11):3050-8. doi: 10.1158/1078-0432.CCR-13-0306. Epub 2013 Mar 27.

  PMID: 23536435 RESULT

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

nimotuzumab; Vinorelbine; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Maura Massimino, MD

  Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, non-blinded, randomised two cohorts study

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: August 8, 2018
• Study Start: November 2, 2015
• Primary Completion: November 11, 2022
• Study Completion: November 2, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)