Adenocarcinoma of the Cervix, Squamous Cell Carcinoma of the Cervix
Conditions
Brief summary
They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.
Interventions
DRUGCIGB300
CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.
Sponsors
Laboratorio Elea Phoenix S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Stages IIA and IIB FIGO classification. * Age between 21 to 70 years. * ECOG performance status 0-1. * No history of another neoplastic disease. * Value of Hemoglobin ≥ 9 g / l. * Total leukocyte count ≥ 3.0 x 109 / L. * Absolute neutrophil count ≥ 1.5 x 109 / L. * Platelets ≥ 100,000 x mm3. * Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal. * Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula) * Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy. * Life expectancy ≥ 12 months * Measurable disease * Informed consent signed by the patient
Exclusion criteria
* Pregnancy and lactation period. * Presence of lymph node metastases or hematogenous extrapelvic known. * Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient. * Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years. * Hepatitis B or C active, positive serology for HIV. * Atopy history of severe / severe asthma. * A history of autoimmune disease. * Presence of significant abnormalities in ECG performed within 14 days prior to admission. * Diseases that prevent the patient give informed consent or their ability to collaborate in the trial. * Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with local relapses | Up to 2 years |
| Number of patients with distant relapses | Up to 2 years |
Countries
Argentina
Outcome results
None listed