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

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000011
• Date of registration: 28/12/2010
• Prospective Registration: No
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: h-R3 MaB and radiotherapy in pediatric patients with intrinsic diffuse astrocytomas of brain stem, phase II.
• Scientific title: Use of h-R3 MaB and radiotherapy in treatment of pediatric patients with intrinsic diffuse astrocytomas of brain stem
• Date of first enrolment: 21/11/2007
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000011-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 2

Countries of recruitment

Cuba

Contacts

• Name: Tania Crombet Ramos
• Affiliation: Center of Molecular Immunology(CIM)

• Name: Tania Crombet Ramos
• Affiliation: Center of Molecular Immunology(CIM)

Key inclusion & exclusion criteria

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.

Age minimum: 3 years
Age maximum: 18 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Intrinsic diffuse astrocytomas of brain stem.

Neoplasms, Glandular and Epithelial

Brain Stem Neoplasms

Central Nervous System Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Brain Diseases

Central Nervous System Diseases

Nervous System Neoplasms

Infratentorial Neoplasms

Brain Neoplasms

Neuroectodermal Tumors

Intervention(s)

Administration, Intravenous

Radiotherapy

Antibodies, Monoclonal, Humanized

One single treatment group to receive first-line therapy for the disease and the product under research. First-line therapy. Conventional radiant treatment. Product under research. h-R3 MAb will be administered in an induction stage and a consolidation stage. Induction stage. 150mg/m2 of MaB will be intravenously administered (antecubital vein), in 250ml saline solution (0.9% NaCl) for one hour, once a week, during 8 weeks. In the ninth week, the objective antitumoral response will be evaluated. If evidence of objective antitumoral response (stabilization, partial regression or complete regression) is found, the consolidation stage will begin. Consolidation stage. 150mg/m2 of MAb will be intravenously administered (antecubital vein) in 250ml saline solution (0.9% NaCl) for one hour, every 2 weeks, until the 18th week (10th, 12th, 14th, 16th and 18th weeks), totaling 13 injections. Once this stage is completed, patients can continue on MAb every 2 weeks, at the suggestion of the clinical researcher, provided that no tumoral progression or intolerable adverse reactions are found.

AcMh-R3

Antibodies, Monoclonal

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

CRD-EC097

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable