PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides

Phase 4

Terminated

• Conditions: Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
• Interventions: Drug: PUVA (8-MOP + UVA); Drug: PUVA (8MOP + UVA) + IFN

• Registration Number: NCT00630903
• Lead Sponsor: Madrilenian Group of Cutaneous Lymphomas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2003-01
• Status Verified: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Last Update Submitted: 2008-03-06
• Study First Posted: 2008-03-07
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PUVA (8-MOP + UVA)	8-MOP + UVA x 24 weeks
B	PUVA (8MOP + UVA) + IFN	IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy of PUVA vs PUVA + IFN	Weeks 4, 8, 12, 16 and 24

Trial Locations

Locations (9)

Hospital Gómez Ulla; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital de la Princess; 🇪🇸 Madrid, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Príncipe de Asturias.; 🇪🇸 Alcalá de Henares, Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain