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

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ClinicalTrials.gov Identifier: NCT02199327
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : August 8, 2017
Sponsor:
Collaborators:
Instituto Mexicano del Seguro Social
University of Guadalajara
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : July 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Recurrence of conjunctival-corneal intraepithelial neoplasia [ Time Frame: One year ]
    Watch at least one year after the resolution of the lesion to detect recurrence.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199327


Locations
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Mexico
IMSS Centro Médico de Occidente
Guadalajara, Jalisco, Mexico
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Instituto Mexicano del Seguro Social
University of Guadalajara
Investigators
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Principal Investigator: Alvarado Beatriz, M.D. Instituto Mexicano del Seguro Social
More Information
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Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02199327    
Other Study ID Numbers: R-2012-785-094
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we intend to publish the results as a scientific article with all results of participants
Keywords provided by Coordinación de Investigación en Salud, Mexico:
Conjunctival-corneal intraepithelial neoplasia
Mitomycin C
Interferon alfa 2b
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Interferons
Interferon-alpha
Interferon alpha-2
Mitomycins
Mitomycin
 Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors