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

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ClinicalTrials.gov Identifier: NCT00630903
Recruitment Status : Terminated (Insufficient accrual)
First Posted : March 7, 2008
Last Update Posted : March 7, 2008
Sponsor:
Information provided by:
Madrilenian Group of Cutaneous Lymphomas

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.

Condition or disease Intervention/treatment Phase
Cutaneous T-Cell Lymphoma (Mycosis Fungoides) Drug: PUVA (8MOP + UVA) + IFN Drug: PUVA (8-MOP + UVA) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
Study Start Date : January 2000
Estimated Primary Completion Date : January 2003


Arm Intervention/treatment
Active Comparator: A
8-MOP + UVA x 24 weeks
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)
Active Comparator: B
IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
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)



Primary Outcome Measures :
  1. Efficacy of PUVA vs PUVA + IFN [ Time Frame: Weeks 4, 8, 12, 16 and 24 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630903


Locations
Spain
Hospital Príncipe de Asturias.
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital de la Princess
Madrid, Spain, 28009
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Fundación Jiménez Díaz
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gómez Ulla
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Sponsors and Collaborators
Madrilenian Group of Cutaneous Lymphomas
Investigators
Principal Investigator: Francisco Vanaclocha Sebastián, MD Hospital 12 de Octubre
Principal Investigator: Jesús Fernández Herrera, MD, PhD Hospital de la Princesa

Responsible Party: Dr F Vanaclocha Sebastián, Servicio de Dermatología. Hospital 12 de Octubre
ClinicalTrials.gov Identifier: NCT00630903     History of Changes
Other Study ID Numbers: MF99
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferon-alpha
Methoxsalen
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents