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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Use of h-R3 MaB and radiotherapy in treatment of pediatric patients with intrinsic diffuse astrocytomas of brain stem

Secondary indentifying numbers:

CRD-EC097

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

07/08/2007

Reference number:

000312

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ricardo Cabanas Armada, MD, 2nd degree specialist in Oncology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Villa Clara, José Luis Miranda Pediatric Hospital, Victor Pich León, MD. 1st degree Specialist in oncology. Santiago de Cuba, Infantil Sur Pediatric Hospital, Pausides Perez Aroche, MD. 1st degree Specialist in Pediatric. Holguín, Octavio de la concepción y la Pedraja Pediatric Hospital, Melba Zaldivar Santiesteban, MD. 1st degree Specialist in, neurosurgery

Research ethics committees:

Juan Manuel Marquez Pediatric hospital, June 16, 2007. José Luis Miranda Pediatric hospital, November 2th, 2007 Infantil Sur Pediatric hospital, November 22, 2007 Octavio de la concepción y la Pedraja Pediatric hospital, November 23, 2007.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

21/11/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

3 years

Maximum age:

18 years

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.

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dra. Tania

Last Name:

Crombet Ramos

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba.

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 218.

Email :

taniac@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dra. Tania

Last Name:

Crombet Ramos

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

País:

Cuba.

Zip Code:

CP 16040, Box11600

Telephone:

(537) 271-7933 Ext 218.

Email :

taniac@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000011

Date of Registration in Primary Registry:

2010-12-28

Record Verification Date:

2010-11-01 20:00

Link to the spanish version:

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

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