hR3 MaB and radiotherapy in highly malignant astrocytic tumors, phase III.

Phase 3

• Conditions: Highly malignant astrocytic tumors.; Astrocytoma; Glioma; Neuroectodermal Tumors; Brain Neoplasms; Neoplasms, Neuroepithelial; Neoplasms, Nerve Tissue; Neoplasms, Glandular and Epithelial; Central Nervous System Neoplasms; Nervous System Neoplasms

• Registration Number: RPCEC00000012
• 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: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Patients with highly malignant astrocytic tumors, anaplastic astrocytomas (grade III) or multiform glioblastomas (grade IV), confirmed by Pathological Anatomy techniques. 2) Patients who had undergone surgical treatment up to 4 weeks before being included in the trial and at the time of inclusion are eligible for radiant treatment with Cobalt. Patients should not have been subjected to any other onco-specific treatment. 3) Reproductive-age patients should have a negative pregnancy test and use effective contraceptive methods. 4) Age >= 18 years. 5) Life expectancy >= 12 weeks. 6) General health condition according to the Karnosfsky Index >= 60. 7) Laboratory parameters within normal limits defined as: Hematopoietic parameters: hemoglobin >=9g/l, total leukocytes >= 4x109 cells/l, platelets >= 100x109/l. Liver: liver functioning within normal limits and without any liver condition demonstrated by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine: 132mmol/l. 8) Patients expressing their consent in writing to participate in the study by signing the informed consent document.

Exclusion Criteria

1) Patients on 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 any other similar product. 5) Fever. 6) Severe septic processes. 7) Acute or serious allergic conditions. 8) Presence of a second tumor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time, life expectancy higher than 12 weeks. Measuring time: 12 months.

Secondary Outcome Measures

Name	Time	Method
Progression free intervals, toxicity, and prognostic and predictive value of EGFR expression. Measuring time: 3 months.