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

August 7, 2017 updated by: Coordinación de Investigación en Salud, Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • IMSS Centro Médico de Occidente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • Intron A
  • Urifron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia
Time Frame: 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.
One month to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects with topic therapy
Time Frame: One to two years
Watch as topical treatment is maintained and at least one years after the resolution of the lesion.
One to two years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of conjunctival-corneal intraepithelial neoplasia
Time Frame: One year
Watch at least one year after the resolution of the lesion to detect recurrence.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

University of Guadalajara
Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Alvarado Beatriz, M.D., Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2012-785-094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

we intend to publish the results as a scientific article with all results of participants

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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