PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides (MF99)

March 6, 2008 updated by: Madrilenian Group of Cutaneous Lymphomas

Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.

The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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

  • Spain
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Fundacion jimenez diaz
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28009
        • Hospital de la Princess
      • Madrid, Spain
        • Hospital Gómez Ulla
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Hospital Príncipe de Asturias.
      • Getafe, Madrid, Spain
        • Hospital Universitario de Getafe

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mycosis fungoides Stage Ia Ib IIa
  • Written informed consent
  • 18-70 y.o., both sex
  • No concomitant systemic disease

Exclusion Criteria:

  • Pregnant or lactating women
  • Fertile women not accepting contraception
  • Medical history of melanoma or non melanoma skin cancer
  • Concomitant infections
  • Immunodeficiency states
  • Previous Heart disease
  • Respiratory insufficiency
  • Chronic RRenal insufficiency
  • Chronic hepatopathy
  • Epilepsy
  • Depression
  • Leucocytes <3000 or neutrophiles <1000 or thrombocytes <100000 or hemoglobin <12 gr/dL or ANA <1/80
  • Treatment with systemic steroids
  • Altered thyroid hormones
  • Previous resistance to PUVA and/or IFN
  • Hypersensitivity to IFN
  • Patients under treatment with teophiline and/or dicumarol
  • Previous total skin electron beam
  • Wash up period less than 3 month for IFN and /or PUVA
  • Wash up period less than 1 month for topical treatments

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
8-MOP + UVA x 24 weeks
Drug: PUVA (8-MOP + UVA)
Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)
ACTIVE_COMPARATOR: B
IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
Drug: PUVA (8MOP + UVA) + IFN
Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of PUVA vs PUVA + IFN
Time Frame: Weeks 4, 8, 12, 16 and 24
Weeks 4, 8, 12, 16 and 24

Collaborators and Investigators

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

Sponsor

Madrilenian Group of Cutaneous Lymphomas

Investigators

  • Principal Investigator: Francisco Vanaclocha Sebastián, MD, Hospital 12 de octubre
  • Principal Investigator: Jesús Fernández Herrera, MD, PhD, Hospital de La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2000

Primary Completion (ANTICIPATED)

January 1, 2003

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (ESTIMATE)

March 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF99

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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