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

NCT ID: NCT02199327

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Conjunctival Intraepithelial Neoplasia Corneal Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mitomycin C

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

Group Type ACTIVE_COMPARATOR

Mitomycin C

Intervention Type DRUG

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).

Interferon alfa 2b

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

Group Type ACTIVE_COMPARATOR

Interferon Alfa-2b

Intervention Type DRUG

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

Interventions

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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).

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Mutamycin Mitomycin Urifron Intron A

Eligibility Criteria

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Inclusion Criteria

* Patients with clinical diagnosis of corneal and conjunctival intraepithelial neoplasia (CIN) with no history of ocular neoplasia

Exclusion Criteria

* Patients who did not agree to participate in the study.
* Patients with corneal abrasion
* Patients who have the diagnosis of CIN, but are pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role collaborator

University of Guadalajara

OTHER

Sponsor Role collaborator

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alvarado Beatriz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

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IMSS Centro Médico de Occidente

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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R-2012-785-094

Identifier Type: -

Identifier Source: org_study_id

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