PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides

Cutaneous T-Cell Lymphoma (Mycosis Fungoides) Clinical Trial

— MF99  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00630903
• Other study ID #: MF99
• Status: Terminated
• Phase: Phase 4
• First received: February 28, 2008
• Last updated: March 6, 2008
• Start date: January 2000

Study information

• Verified date: February 2008
• Source: Madrilenian Group of Cutaneous Lymphomas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides

Intervention

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)
• 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)

Locations

Country	Name	City	State
Spain	Hospital Príncipe de Asturias.	Alcalá de Henares	Madrid
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital de la Princess	Madrid
Spain	Hospital Gómez Ulla	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Madrilenian Group of Cutaneous Lymphomas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PUVA vs PUVA + IFN		Weeks 4, 8, 12, 16 and 24	Yes