RPCEC00000229Not yet recruitingPhase 1
Study adaptive, randomized, open, controlled, multicenter Phase I-II, of HEBERFERON use in patients with renal cell carcinoma stage III-IV
Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 sites270 target enrollmentStarted: January 5, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 270
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to one (—)
- Sex
- All
Inclusion Criteria
- •1. Characteristics of the disease:
- •1.1. Histological or cytological diagnosis of stage III or IV renal cell carcinoma after nephrectomy.
- •1.2. Measurable or non-measurable disease that includes any of the following:
- •1.2.1. Measurable lesion in a dimension = 20 mm by conventional methods (physical examination, X-ray) or 10 mm by CT or MRI.
- •The following are considered non-measurable diseases:
- •-Lessions small.
- •-Lion in bone
- •-Leptomeningeal disease
- •- Pleural / pericardial fusion
- •- Lymphangitis cutis / pulmonis.
- •Abdominal mass not confirmed and followed by imaging techniques.
- •- Cystic lesions.
- •- Irradiated lesions, while progression is not documented after radiotherapy.
- •-1.3. Availability of non-stained paraffin blocks or sheets.
- •-1.4. Imaging evaluation that defines the absence or presence of metastases (CT, MRI or other available).
- •2. Characteristics of patients:
- •2.1. Age =18 years, any gender and race.
- •2.2. ECOG =2 / KPS=70.
- •2.3. Hematopoietic parameters
- •2.3.1. Granulocyte count = 1.5 x 109 / L
- •2.3.2. Platelet count = 100 x 109 / L
- •2.3.3. No clinical history of significant bleeding.
- •2.4. Hepatic parameters
- •2.4.1. ASAT / ALAT = 2.5 upper limit of normal (LNS)
- •2.4.2. Alkaline phosphatase 2.5 = LNS
- •2.4.3. Bilirubin = 1.5 LNS
- •2.5. Renal parameters
- •2.5.1. Creatinine = 1.5 LNS
- •2.5.2. Without proteinuria> 1+
- •2.5.3. Proteinuria = 2+ allowed with protein <2 g / 24-hour in the urine
- •2.6. Clinical condition and parameters (hematopoietic, hepatic, renal and cardiac) in the ranges established previously after the FC / FD study
- •3. Previous or concurrent therapies.
- •4. Other types of prior or concurrent antitumor treatments are not prohibited or to compensate for non-decompensated chronic noncompensated chemical, radiation, biological, endocrine, or concomitant diseases.
- •5. Surgery.
- •At least 4 weeks after surgery and with regrowth criteria.
- •6.1. Negative pregnancy test.
- •6.2. Patients of childbearing potential should use an effective contraceptive method.
- •6.3. Express written willingness of the patient.
Exclusion Criteria
- •1. Cardiovascular parameters.
- •1.1. Myocardial infarction in the last 6 months prior to the administration of the product.
- •1.2. Severe or unstable angina
- •1.3. Implant of coronary or peripheral bypass.
- •1.4. Symptomatic congestive heart failure.
- •1.5. Stroke or transient ischemic attack.
- •1.6. Pulmonary embolism.
- •1.7. Presence of ventricular arrhythmias = grade 2
- •1.8. Absence of HPA which cannot be controlled by drugs.
- •2. Pregnancy, postpartum and breastfeeding.
- •3. Active infection requiring any specific treatment.
- •4. ALT or AST> 5 times the normal reference range.
- •5. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, ischemic heart disease or other symptomatic cardiovascular disease, epilepsy, severe mental depression).
- •6. Antecedents of severe allergic urticarial, atopic dermatitis, bronchitis or persistent bronchial asthma or any ingredients of the formulations under study.
- •7. Obvious mental disability or other limitation that prevents the patient to sign the consent or difficult study evaluations.
Investigators
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