Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Conditions
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.
Interventions
DRUGPUVA (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)
DRUGPUVA (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
Madrilenian Group of Cutaneous Lymphomas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of PUVA vs PUVA + IFN | Weeks 4, 8, 12, 16 and 24 |
Countries
Spain
Outcome results
None listed