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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: RPCEC
Last refreshed on: 30 June 2014
Main ID:  RPCEC00000011
Date of registration: 28/12/2010
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:  http://rpcec.sld.cu/trials/RPCEC00000011-En
Study type:  Interventional
Study design:  Randomization: N/A: single arm study Blinding: Open Control: Uncontrolled Assignment: Single group Purpose: Treatment  
Countries of recruitment
Contacts
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.
Intervention(s)
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.
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
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