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

Madrilenian Group of Cutaneous Lymphomas

Status and phase: Terminated; Phase 4

Conditions: Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

Treatments: Drug: PUVA (8-MOP + UVA); Drug: PUVA (8MOP + UVA) + IFN

Study type: Interventional

Funder types: Other

Identifiers

NCT00630903

MF99

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

A

Active Comparator group

Description:

8-MOP + UVA x 24 weeks

Treatment:

Drug: PUVA (8-MOP + UVA)

B

Active Comparator group

Description:

IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks

Treatment:

Drug: PUVA (8MOP + UVA) + IFN