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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000012
• Date of registration: 28/12/2010
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: hR3 MaB and radiotherapy in highly malignant astrocytic tumors, phase III.
• Scientific title: Use of hR3 MaB and radiotherapy in treatment of patients with highly malignant astrocytic tumors, phase III.
• Date of first enrolment: 28/02/2005
• Target sample size: 80
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000012-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba.

Contacts

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

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

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-EC069

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable