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

NCT02199327 | Completed Phase 4 DMC

• 1 other identifier: R-2012-785-094
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctival Intraepithelial Neoplasia; Corneal Intraepithelial Neoplasia

Keywords

Conjunctival-corneal intraepithelial neoplasia; Mitomycin C; Interferon alfa 2b

Outcome Measures

Primary Outcomes (1)

• Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia

  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 Outcomes (1)

• Adverse effects with topic therapy

  One to two years

Other Outcomes (1)

• Recurrence of conjunctival-corneal intraepithelial neoplasia

  One year

Study Arms (2)

Mitomycin C

ACTIVE COMPARATOR

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

Drug: Mitomycin C

Interferon alfa 2b

ACTIVE COMPARATOR

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

Drug: Interferon Alfa-2b

Interventions

Mitomycin C 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).

Also known as: Mutamycin, Mitomycin

Mitomycin C

Interferon Alfa-2b 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

Also known as: Urifron, Intron A

Interferon alfa 2b

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator
• University of Guadalajara: collaborator

Study Sites (1)

IMSS Centro Médico de Occidente

Guadalajara, Jalisco, Mexico

Location

MeSH Terms

Interventions

Mitomycin; Interferon alpha-2; Introns

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Alvarado Beatriz, M.D.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 24, 2014
• Study Start: May 1, 2014
• Primary Completion: December 16, 2016
• Study Completion: July 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)