Squamous cell carcinoma interferons (CECIN study)

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000144
• Date of registration: 01/02/2013
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: Squamous cell carcinoma interferons (CECIN study)
• Scientific title: Open study, single center, perilesional and intralesional application of HeberPAG ® in squamous carcinomas of the skin, stage I and II
• Date of first enrolment: 01/06/2010
• Target sample size: 27
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000144-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: Iraldo Yaquelin Bello-Rivero, PhD. Duncan-Roberts, MD.
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

• Name: Yaquelin Duncan-Roberts, MD.
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Clinical and histological diagnosis of ECC. 2. > 18 years of age. 3. Lesions between 1.5 - 5.0 cm. 4. Invasive clinical subtype, from any location and photo type of skin. If the patient has more than one lesion, the largest that falls within the range of inclusion (1.5 - 5.0 cm) will be treated.
Exclusion criteria: 1. Pregnancy, postpartum or breastfeeding women. 2. Hypersensitivity to HeberPAG or other preparations used in the study. 3. Intraepithelial clinical subtypes or "in situ" of the ECC (Actinic keratosis, Bowen's Disease / Erythroplasia of Queirat, keratoacanthoma). 4. Uncompensated severe arterial hypertension proven by clinical examination. 5. Chronic arterial insufficiency reported by patients and verified by physical examination 6. Diabetes mellitus, Sickle-cell disease. 7. Severe hematological disorders, checked by complementary laboratory measurements (hemoglobin <10 g/l in women and 11 g/l in men). 8. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient and verified by clinical and laboratory examinations (AST, ALT, alkaline phosphatase, bilirubin, creatinine, serum amylase). 9. Very committed general condition (cachexia, severe debilitating disease patients). 10. Patients treated with steroids, immunosuppressants, IFN alpha or gamma in the last three months. 11. Patients receiving other specific cancer treatment at the time of inclusion. 12. Other malignancies and immunological diseases reported by the patient and confirmed by clinical examination. 13. Severe psychiatric disorders or other constraints that prevent the patient's consent or hinder evaluation.

Age minimum: 18 years
Age maximum: N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Squamous cells carcinoma

Intervention(s)

Perilesional and Intralesional treatment of HeberPAG, dose of 11.5 MUI, three times per week for 3 weeks, as outpatient.

Primary Outcome(s)

Clinical Response (size of the lesion- tangible and residual injury). Measuring time: at baseline and at week 16 after starting the treatment. Histological characteristics (Absence of tumor, Presence of tumor). Measuring time: at baseline and at week 16 after starting the treatment. Clinical response time(in weeks). Measuring time: Weeks 1, 2, 3 4, 6, 8, 10, 12, 14 and 16.

Secondary Outcome(s)

Quality of scarring (Good, Regular or Bad). Measuring time: Will be evaluated since the clinical standpoint, in patients that respond completely to treatment, on the 16 week of having started the treatment and during follow-up, which will be three months during the 1st year, half in the 2nd and 3rd and annually in the 4th and 5th year. Scarring Good: • Color: normocromía, slight or slight hypochromia hyperchromia. • Volume: flat lesion, slight slight atrophy or hypertrophy. • Sensitivity: normal. Regular Scarring: • Color: moderate or moderate hypochromia hyperchromia • Volume: moderate moderate hypertrophy or atrophy. • Sensitivity: Light to moderate hyperesthesia, hypoesthesia, spontaneous pain or itching. Scarring Bad: • Color: hyperchromia severe, or severe hypochromia achromia. • Volume: severe hypertrophy, keloid or severe atrophy. • Sensitivity: Severe hyperesthesia, hypoesthesia, anesthesia, spontaneous pain or pruritus. Time to recurrence (Time elapsing from the first day provided the absence of neoplastic cells according to the evaluation histological or clinical (patient refusal to biopsy end or biopsy no useful), until appears an injury histologically demonstrated in the treated site. Measuring time: Months 3, 6, 9, 12, 18, 24, 48, 60. Severe adverse events (Yes, No) Measuring time: At each dose during the 3 weeks of treatment. Anti-IFN alpha and gamma antibodies by ELISA (Patients that develop antibodies (Yes, No)). Measuring time: before treatment and on the 16 week of having started the treatment.

Secondary ID(s)

IG/AGI/NE/0901

Source(s) of Monetary Support

- Center for Genetic Engineering and Biotechnology, Havana. - Ministry of Public Health (MINSAP).

Secondary Sponsor(s)

Not applicable