Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

Study Overview
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Brief Summary
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They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.

Official Title
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Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation

Conditions
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Squamous Cell Carcinoma of the Cervix, Adenocarcinoma of the Cervix

Intervention / Treatment
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* Drug: CIGB300


Participation Criteria
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Eligibility Criteria
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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 

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIGB300<br> | Drug: CIGB300<br>* CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with local relapses |  | Up to 2 years | 
| Number of patients with distant relapses |  | Up to 2 years |