TS-FARMEV Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000112
• Date of registration: 16/05/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: TS-FARMEV Study
• Scientific title: Safety clinical trial and pharmacological evaluation of intravenous administration of CIGB-300 in patients with solid tumors refractory to oncospecific treatment.
• Date of first enrolment: 07/06/2010
• Target sample size: 14 - 20
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000112-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: Dose-escalation

Countries of recruitment

Cuba

Contacts

• Name: Dr. Idania Baladron Castrillo
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Lidia González Méndez
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

Inclusion criteria: 1) Histological diagnosis of a solid tumor refractory to treatment oncospecific. 2) That the patient did not receive more than 2 lines of chemotherapy. 3) last cycle of chemotherapy 4 to 8 weeks after treatment ends oncospecific. 4) Age between 18-75 years inclusive. 5) Written consent from the patient.
Exclusion criteria: 1) Pregnancy and lactation 2) decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy, severe mental depression). 3) moderate or severe systemic infections that interfere with patient evaluation. 4) Patients with previous diagnosis of bleeding disorders and other chronic decompensated hematopatías (hemophilia, leukemia, etc.). 5) Values ??in clinical laboratory evaluations were normal limits prior to the start of treatment: 6) referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory properties. 7) Autoimmune diseases (lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and previous severe allergic urticaria, dermatitis, bronchitis, bronchial asthma and persistent. 8) diseases that compromise the patient's consciousness or his ability to give informed consent or cooperate in the trial. 9) Have been included in another trial in the last 8 weeks.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Solid tumors refractory to oncospecific treatment.

Intervention(s)

It CIGB-300 administered intravenously using a dose-finding design sequentially, based on a continuous reallocation method of dose escalation. The doses to be studied will be: - 0.2 mg/kg - 0.4 mg/kg - 0.8 mg/kg - 1.6 mg/kg We will start with an initial dose of 0.2 mg / kg up to the maximum tolerated dose (MTD) of the study. Patients will receive 3 cycles of IGBC-300 with daily treatments for 5 days on weeks 1, 3 and 5. Patient will receive Diphenhydramine 1 ampoule (50 mg) and Hydrocortisone 1 bulb (100 mg) intravenously 30 minutes before receiving the dose of IGBC-300 question.

Primary Outcome(s)

Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: days or hours; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: 30 minutes and hour, 2, 4, 8 and 12 hours after administration of each dose of CIGB-300. Percent maximum uptake (maximum percentage is the fraction of injected activity that is captured or incorporated by an organ or tumor and is determined as: Activity (tmax) 100/Actividad Injected, where tmax is the time it reaches the maximum incorporation). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Fraction of incorporation (is the total fraction of injected activity that is incorporated into an organ or tumor and is determined as total activity incorporated / injected activity). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Fraction of elimination (total fraction of injected activity that is eliminated by an organ or tumor and is determined as total activity eliminated / injected activity). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Average time biological uptake (is the average time that the activity taken to an organ or tumor increases to half of its value and is determined as: ln (2)/k, where k is the constant of biological incorporation). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Average time biological removal (is the average time that the activity taken to an organ or tumor decreased to half its value and is determined as: ln (2)/k where k is the biological elimination constant). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose.

Secondary Outcome(s)

Evaluation of tumor response, if necessary through imaging tests (tumor diameter). Measuring time: 45 days after treatment ended, and every 3 months until the year into the study.

Secondary ID(s)

IG/CIGB-300 I/TS/0901

Source(s) of Monetary Support

HeberBiotec S.A. Biorec S.A.

Secondary Sponsor(s)

Ministry of Public Health, Cuba.