HeberPAG® in Mycosis Fungoides (MYFIC Study)

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000130
• Date of registration: 08/06/2012
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: HeberPAG® in Mycosis Fungoides (MYFIC Study)
• Scientific title: Exploratory trial of the systemic application of CIGB-128 (HeberPAG®) in Mycosis Fungoides, stages Ib to III
• Date of first enrolment: 08/10/2009
• Target sample size: 12
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000130-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Yanelda Iraldo Idrian García-Vega, MSc Bello-Rivero, PhD García-García, MSc
• Affiliation: Center for Genetic Engineering and Biotechnology

• Name: Yanelda Idrian Garcia-Vega Garcia-Garcia
• Affiliation: Center for Genetic Engineering and Biotechnology.

Key inclusion & exclusion criteria

Inclusion criteria: 1)Clinical and histological diagnosis of Mycosis Fungoides at stages IB, IIA, IIB, III, 2) Age between 18 and 75 years-old, both sex and any race. 3) Patients with measurable lesions, 4) Patients with more than 6 months of expectative of life, Karnofsky’s index superior or equal to 60%, 5) In case of patients that have received previous specific treatment a one-month washout period have to occur; 3 months for the case of patients treated with steroid (immunosuppressor) drugs, 6) Patients in fertile age that use contraceptive methods until three months after the treatment have been concluded, 7) Written, informed consent to participate.
Exclusion criteria: 1) Pregnancy, puerperium, or nursing, 2) Hypersensibility to CIGB-128 (HeberPAG®) u other preparations used in the trial, 3) Uncompensated severe hypertension proven by clinical examination, 4) Chronic arterial insufficiency referred by the patient and proven through clinical examination, 5) Respiratory insufficiency or ischemic cardiopathy, 6) Diabetes Mellitus, Sickle cell disease or drepanocytic anemia, 7) Severe hematological affectations, proven by laboratory data (hemoglobin <100 g/L in women and <10 g/L in men), 8) Diseases with metabolic compromise (hepatopathies, nephropaties, pancreatopathies, collagenopathies) referred by the patient and proven through by laboratory and clinical examinations (AST, ALT, alkaline phosphatase, bilirrubin, creatinina, serum amylase), 9) Very compromised general state (cachexia, patients under a severe state, debilitating diseases), 10) Patients receiving other oncologic specific treatment or steroids at entry, 11) Patients under theophylline and/or anticoagulant treatments, 12) Other neoplasia, immunological diseases or concomitant infections referred by the patient and proven by the clinical examination, except for no-melanoma skin cancer, 13) Severe psychiatric dysfunction or other limitation that impede the patient to give their consent or difficult their evaluation.

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

Health Condition(s) or Problem(s) studied

Mycosis Fungoides

Intervention(s)

A phase I, open-label, non-controlled study with a one group of treatment will be carried out in a unique center. - The treatment will divide in two phases: induction and maintenance. - Intramuscular doses of 11.5 millions IU (IFN alpha-2b 10 millions IU and IFN gamma 1.5 millions IU) of the studied drug will be administered intramuscularly in a total 2 mL volume. - For pharmacokinetic and pharmacodynamic studies a single initial dose of 23 millions IU will be applied. - At fifth day post-injection, after the 96 hours sampling period, the induction and maintenance stages will be started: 1.Induction: The treatment will be administered 3 times per week during 6 months. 2.Maintenance: The treatment will be administered 2 times per week during 6 months more as minimum or until progression, definitive interruption because adverse events or voluntary abandon of the patient.

Primary Outcome(s)

- Proportion of patients with severe adverse events. Measuring time: one year. - Presence of clinical adverse events (AE) (distribution frequency for the appearance of adverse events (Yes, No), type of event (name of the AE), duration (time between beginning and end of the event), intensity of AE (mild, moderate, severe), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: one year. - Vital signs (body temperature in degrees Celsius, heart rate in beats per minute, blood pressure in mm Hg and respiratory rate in breaths per minute). Measuring time: before treatment, at 30 minutes, each 4 hours during first 24 hours post-first injection, each 12 hours during first week; at each consultation the rest of the time or at any moment if symptoms. - Electrocardiogram. Measuring time: Before treatment, 12 hours after each administration during first week, and later quarterly during first year if no toxicity signs or at any moment if symptoms. - Echocardiogram. Measuring time: Before treatment, 12 hours after each administration during first week, and later quarterly during first year if no toxicity signs or at any moment if symptoms. - Laboratory tests (complete blood count, platelet count, coagulation least ASAT, ALAT, FAL, LDH, creatinine, glucose, total protein, albumin, CPK, electrolytes). Measuring time: week 0, week 1 (before 3rd application), monthly during first 3 months, quarterly during first year and biannually during follow-up (until to complete 5 years). - Proportion of patients that develop anti-IFN antibodies. Measuring time: week 0 and quarterly until to complete the treatment.

Secondary Outcome(s)

- Serum alpha Interferon and gamma Interferon concentrations. Measuring time: Baseline, 1, 3, 6, 12, 24, 48, 72 and 96 hours after first injection. - Serum neopterin. Measuring time: Baseline and 6, 12, 24, 48, 72 and 96 hours after first injection. - Serum beta2-microglobulin. Measuring time: Before and 6, 12, 24, 48, 72 and 96 hours after first injection. - 2',5' oligoadenylate synthetase (2',5' OAS) mRNA expression in peripheral blood. Measuring time: Baseline, 6, 12, 24, 48, 72 and 96 hours after first injection. - Molecular (mRNA STAT-1 levels, FasL, FasR, Caspase). Measuring time: Baseline, 6, 12, 24, 48, 72 and 96 hours after first injection. - Clinical response of the lesions (according to SWAT severity criteria). Measuring time: week 0, monthly during the first trimester, quarterly rest of the year, and biannually during follow-up (until to complete 5 years). - Time to reach clinical response. Measuring time: biannually during treatment and follow-up (until to complete 5 years). - Time of duration of the clinical response. Measuring time: biannually during treatment and follow-up (until to complete 5 years). - Disease-free interval. Measuring time: biannually during treatment and follow-up (until to complete 5 years). - 5-years survival. Measuring time: biannually during treatment and follow-up. - Mean time of survival - 5-years progression. Measuring time: biannually during treatment and follow-up. - Mean time for progression - Quality of life. Measuring time: week 0, months 3, 6, 9 and 12, and biannually during follow-up (until to complete 5 years).

Secondary ID(s)

IG/AGI/NF/0901

Source(s) of Monetary Support

HeberBiotec S.A

Secondary Sponsor(s)

Ministry of Public Health, CUBA