Trial | NCT00630903  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    methoxsalen ...

  • Study Participants

    54
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.
Study Started
Jan 31
2000
Primary Completion
Jan 31
2003
Anticipated
Last Update
Mar 07
2008
Estimate

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)

Drug 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)

A Active Comparator

8-MOP + UVA x 24 weeks

B Active Comparator

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

Criteria 

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
No Results Posted