Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT02199327

Collaborator

Instituto Mexicano del Seguro Social (Other), University of Guadalajara (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial neoplasia.

Condition or Disease	Intervention/Treatment	Phase
Conjunctival Intraepithelial Neoplasia Corneal Intraepithelial Neoplasia	Drug: Mitomycin C Drug: Interferon Alfa-2b	Phase 4

Detailed Description

The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of the ocular surface. Classic treatment is complete excision with safety margins, however, usually the edges are not sharp and difficult clinical differentiation between healthy areas that are not; to this treatment has joined him carrying out cryotherapy bedding and borders . Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been used either as adjuvant or primary treatment . Among the drugs used the investigators have mitomycin C (MMC) and interferon alpha 2b (INFα 2b).

Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined.

Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).

Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Clinical Trial to Compare Topical Interferon Alfa 2b And Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 16, 2016

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mitomycin C Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).	Drug: Mitomycin C Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). Other Names: Mutamycin Mitomycin
Active Comparator: Interferon alfa 2b Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor	Drug: Interferon Alfa-2b Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences Other Names: Urifron Intron A

Arm

Intervention/Treatment

Active Comparator: Mitomycin C

Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).

Drug: Mitomycin C

Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).

Other Names:

Mutamycin

Mitomycin

Active Comparator: Interferon alfa 2b

Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor

Drug: Interferon Alfa-2b

Other Names:

Urifron

Intron A

Outcome Measures

Primary Outcome Measures

Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia [One month to one year]
Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.

Secondary Outcome Measures

Adverse effects with topic therapy [One to two years]
Watch as topical treatment is maintained and at least one years after the resolution of the lesion.

Other Outcome Measures

Recurrence of conjunctival-corneal intraepithelial neoplasia [One year]
Watch at least one year after the resolution of the lesion to detect recurrence.