PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
Lead SponsorMadrilenian Group of Cutaneous Lymphomas
Indication/ConditionCutaneous T-Cell Lymphoma (Mycosis Fungoides)
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.
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)
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)
8-MOP + UVA x 24 weeks
IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
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