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

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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 hR3 MaB and radiotherapy in treatment of patients with highly malignant astrocytic tumors, phase III.

Secondary indentifying numbers:

IIC RD-EC069

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 :

21/09/2004

Reference number:

1804/05.015.04B

Principal investigator

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

First name:

Javier Figueredo, MD. 1st degree Specialist in Neurosurgery.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

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:

Havana City, National Institute of Neurology and Neurosurgery, Francisco Goyenechea Gutiérrez, MD. 1st degree Specialist in Neurosurgery. Camagüey, María Curie Oncological Hospital, Carolina Toledo Jimenez, MD. 1st degree Specialist in Neurocirugia. Holguin, Lucía Inniguez Hospital, Julio Cesar Forest Infante, MD. 1st degree Specialist in Neurosurgery.

Research ethics committees:

Center of Medical-Surgical Researches (CIMEQ), May 3, 2004. National Institute of Neurology and Neurosurgery, April 12, 2004 Maria Curie Oncological Hospital, August 27, 2004 Lucia Iñiguez" Hospital, July 14, 2004

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

28/02/2005

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:

Highly malignant astrocytic tumors.

Intervention(s):

Group I. Radiant+hR3 MAb treatment Forty patients to be included: - Conventional radiant treatment (60Gy). This treatment will be conducted during 6 weeks until hR3 MAb and radiotherapy in highly malignant astrocytic tumors, until reaching the final dose. 1st week 8Gy (+-2Gy), 2nd week 18Gy (+-2Gy), 3rd week 28Gy (+-2Gy), 4th week 38Gy (+-2Gy), 5th week 48Gy (+-2Gy), and 6th week 58Gy (+-2Gy). - h-R3 MAb. One 200mg MAb dose will be administered by intravenous route (antecubital vein) in 25ml saline solution (0.9% NaCl), once a week, for 6 weeks. Once the radiant therapy is completed, patients will receive one 200mg hR3 MAb maintenance dose every 21 days until reaching one year treatment. Group II. Radiant+Placebo treatment Forty patients to be included: - Conventional radiant treatment (60Gy). The same way as in Group I. - Placebo. Four placebo bulbs will be administered by intravenous route (antecubital vein) in 250ml saline solution (0.9% NaCl), once a week, for 6 weeks. Once the radiant therapy is completed, patients will receive 4 placebo bulbs every 21 days until reaching one year treatment.

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):

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

Key secondary outcomes:

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

18 Years

Maximum age:

No limit

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.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

3

Target sample size:

80

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:

Tania

Last Name:

Cormbet Ramos

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Hvana City

Country:

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:

Tania

Last Name:

Crombet Ramos

Affiliation:

Center of Molecular Immunology(CIM)

Postal Address:

Calle 216 Esquina 15, Atabey, Playa

City:

Havana City

Country:

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:

RPCEC00000012

Date of Registration in Primary Registry:

2010-12-28

Record Verification Date:

2010-11-01 20:00

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

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