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Trial record 3 of 119 for:    MOPS

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

This study has been terminated.
(Insufficient accrual)
Sponsor:
Information provided by:
Madrilenian Group of Cutaneous Lymphomas
ClinicalTrials.gov Identifier:
NCT00630903
First received: February 28, 2008
Last updated: March 6, 2008
Last verified: February 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Madrilenian Group of Cutaneous Lymphomas:

Primary Outcome Measures:
  • Efficacy of PUVA vs PUVA + IFN [ Time Frame: Weeks 4, 8, 12, 16 and 24 ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: January 2000
Estimated Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630903

Locations
Spain
Hospital Príncipe de Asturias.
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital de la Princess
Madrid, Spain, 28009
Hospital Gómez Ulla
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
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
  More Information

No publications provided

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
Study First Received: February 28, 2008
Last Updated: March 6, 2008
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycoses
Mycosis Fungoides
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Methoxsalen
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014