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PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides

NCT00630903 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2008-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Interventions

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)

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)

Sponsors & Collaborators

  • Madrilenian Group of Cutaneous Lymphomas

    lead OTHER

Principal Investigators

  • Francisco Vanaclocha Sebastián, MD · Hospital 12 de Octubre

  • Jesús Fernández Herrera, MD, PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2003-01-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630903 on ClinicalTrials.gov