h-R3 MaB and radiotherapy in pediatric patients with intrinsic diffuse astrocytomas of brain stem, phase II.

Phase 2

Recruiting

• Conditions: Intrinsic diffuse astrocytomas of brain stem.; Astrocytoma; Brain Stem Neoplasms; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Infratentorial Neoplasms; Brain Neoplasms; Brain Diseases

• Registration Number: RPCEC00000011
• Lead Sponsor: Center of Molecular Immunology(CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Pediatric patients with intrinsic diffuse gliomas of brain stem, confirmed by histological or radiological techniques in case of non-biopsy-susceptible brain stem lesions. 2) Patients eligible for Cobalt60 radiant treatment. Patients should not have been subjected to any other onco-specific treatment. 3) Age: 3 years or older and 18 years or younger. 4) Patients with measurable lesions defined as those that can be accurately measured in, at least, 2 dimensions using conventional techniques (CAT, NMR). 5) Reproductive-age females should have a negative pregnancy test and use effective contraceptive methods under active sexual life. 6) Reproductive-age males should use effective contraceptive methods under active sexual life. 7)Life expectancy = 12 weeks. 8)General health condition according to the Karnosfsky Index >= 60% (Karnosfsky Index for patients >16 years), Lansky >= 60% (for patients <=16 years) 9) Laboratory parameters within normal limits defined as: Hematopoietic parameters: hemoglobin>=10g/l, total leucocytes>= 2x109cells/l, platelets >= 100x109/l. Liver: liver functioning within normal limits and without any liver affliction demonstrated by TGP, TGO <= 2.5 above reference value, and total bilirubin 1.5 above reference value. Kidney function: serum creatinine <= 1.5 above reference value. 10) Parents or legal guardians should express their consent in writing for the patient to be included in the study by signing the informed consent document. Following the researcher’s criterion, minor’s consent should be obtained wherever possible.

Exclusion Criteria

1) Patients previously treated with any MAb. 2) Pregnancy or breastfeeding. 3) Patients who, at the time of inclusion, have a decompensated related chronic disease (for example, cardiopathy, diabetes, high blood pressure). 4) Patients with history of hypersensitivity to this or other similar product. 5) Fever, severe septic processes and/or acute or severe allergic conditions. 6) Patients participating in another clinical trial for therapeutic purposes for base disease at the time of inclusion in this study. 7) Presence of a second tumor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS). Measuring time: 6 months.

Secondary Outcome Measures

Name	Time	Method
Global survival time, objective antitumoral response, response duration, and toxicity. Measuring time: 12 months.