Status:
TERMINATED
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
Lead Sponsor:
Madrilenian Group of Cutaneous Lymphomas
Conditions:
Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Mycosis fungoides Stage Ia Ib IIa
- Written informed consent
- 18-70 y.o., both sex
- No concomitant systemic disease
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00630903
Start Date
January 1 2000
Last Update
March 7 2008
Active Locations (9)
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1
Hospital Príncipe de Asturias.
Alcalá de Henares, Madrid, Spain
2
Hospital Universitario de Getafe
Getafe, Madrid, Spain
3
Hospital de la Princess
Madrid, Madrid, Spain, 28009
4
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041