- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00630903
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides (MF99)
March 6, 2008 updated by: Madrilenian Group of Cutaneous Lymphomas
Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
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 Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Madrid, Spain
- Hospital Ramon y Cajal
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain
- Fundacion jimenez diaz
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Madrid, Spain
- Hospital La Paz
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Madrid, Spain
- Hospital Clinico San Carlos
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Madrid, Spain, 28009
- Hospital de la Princess
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Madrid, Spain
- Hospital Gómez Ulla
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-
Madrid
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Alcalá de Henares, Madrid, Spain
- Hospital Príncipe de Asturias.
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Getafe, Madrid, Spain
- Hospital Universitario de Getafe
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: A
8-MOP + UVA x 24 weeks
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of PUVA vs PUVA + IFN
Time Frame: Weeks 4, 8, 12, 16 and 24
|
Weeks 4, 8, 12, 16 and 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francisco Vanaclocha Sebastián, MD, Hospital 12 de octubre
- Principal Investigator: Jesús Fernández Herrera, MD, PhD, Hospital de La Princesa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (ANTICIPATED)
January 1, 2003
Study Registration Dates
First Submitted
February 28, 2008
First Submitted That Met QC Criteria
March 6, 2008
First Posted (ESTIMATE)
March 7, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
March 7, 2008
Last Update Submitted That Met QC Criteria
March 6, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Bacterial Infections and Mycoses
- Lymphoma
- Lymphoma, T-Cell
- Mycoses
- Lymphoma, T-Cell, Cutaneous
- Mycosis Fungoides
- Photosensitizing Agents
- Dermatologic Agents
- Methoxsalen
Other Study ID Numbers
- MF99
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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