Highly malignant astrocytic tumors.
Conditions
Interventions
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 mali
Antibodies, Monoclonal, Humanized
Radiotherapy
Antibodies, Monoclonal
Administration, Intravenous
Placebos
Sponsors
Center of Molecular Immunology(CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time, life expectancy higher than 12 weeks. Measuring time: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free intervals, toxicity, and prognostic and predictive value of EGFR expression. Measuring time: 3 months. | — |
Countries
Cuba.
Contacts
Public ContactTania Crombet Ramos
Center of Molecular Immunology (CIM)
Outcome results
None listed