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PUVA Maintenance Therapy in Mycosis Fungoides

Information source: Medical University of Graz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patch/Plaque Stage Mycosis Fungoides

Intervention: 8-methoxypsoralen (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Medical University of Graz

Official(s) and/or principal investigator(s):
Peter Wolf, MD, Principal Investigator, Affiliation: Medical University of Graz

Overall contact:
Peter Wolf, MD, Phone: +43 316 385, Ext: 80315, Email: peter.wolf@medunigraz.at

Summary

The purpose of the study is to determine whether psoralen plus UVA (PUVA) photochemotherapy maintenance treatment prolongs disease-free survival of cutaneous T cell lymphoma (mycosis fungoides) patients.

Clinical Details

Official title: A Multi-center, Randomized Study on Oral 8-methoxypsoralen Plus UVA With or Without Maintenance Therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIB

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Recurrence after complete remission within 12 months post therapy

Secondary outcome:

Quality of life

HADS

Cytokine response in serum

Levels of regulatory T cells

Function of regulatory T cells

Microscopic alterations

Cytokine expression in the skin

Detailed description: Background: Psoralen plus UVA (PUVA) photochemotherapy consists of the topical or oral application of psoralen, followed by exposure to UVA light. PUVA is used in various conditions, including early stages of mycosis fungoides (MF) and other primary and secondary lymphoproliferative disorders. PUVA has strong pro-apoptotic and immunomodulating properties, but the exact mechanisms by which PUVA leads to clearance of MF are not well understood. Although MF is generally a slowly progressing disease, it ultimately can spread to lymphoid tissues, peripheral blood, and other organs, leading to death. Previous Work: PUVA therapy is a well-accepted first-line treatment option for skin-limited MF (stages IA, IB, and IIA), leading to complete remission in a high portion of patients (approximately 70 to 90%). Long-term remissions can be achieved with PUVA in a certain percentage of patients. However, in most cases MF lesions relapse after stop of PUVA after variable time intervals with a median time to relapse of 14 to 17 month, according to our own experience. Not only is little is known about the therapeutic mechanisms of PUVA in MF but as little is known about optimal duration and frequency of treatment (2, 3, or 4 times weekly), dose escalation, and maintenance therapy. Although PUVA has been introduced more than 30 years ago, there is lack of prospective controlled studies with clearly defined dose schemes and also an ongoing controversy whether PUVA maintenance therapy may prolong disease remission in MF upon initial complete clearance. Hypothesis & Intended Work: We hypothesize that PUVA prolongs disease free survival in MF patients. In a randomized multicenter trial involving 9 centers in Austria, we plan to investigate (1) the clinical efficacy of PUVA and its maintenance therapy in MF and, (2) the mechanisms by which PUVA leads to disease clearance. In total, 82 patients will be enrolled and treated with a defined PUVA regimen with 2 exposures per week for 12 weeks. After 12 weeks of PUVA treatment, patients with complete remission will be randomized into two arms. In Arm A patients will be treated with PUVA maintenance therapy at constant single UVA doses. Maintenance treatment will be given once a week for one month (4 weeks), every 2 weeks for 2 months (8 weeks) and after three months once a month over 6 months. After 9 months of maintenance therapy patients will discontinue therapy. Patients in Arm B will receive no therapy. Thereafter, all patients will be followed until recurrence or at least 12 months (in non-recurrent patients) when the primary study analysis will be done. In addition, the follow-up will be extended to 60 months for long-term results. The mechanistic action of PUVA will be studied by laboratory investigations, including immune function and cytokine analysis. Outlook: A better understanding of the optimal regimen and the therapeutic mechanisms of PUVA in MF should help improving treatment strategies for this life-threatening disease. The understanding of the mode of action of PUVA in MF may also help to develop novel treatments using PUVA-affected pathways, allowing to achieve overall better long-term response and success.

Eligibility

Minimum age: 18 Years. Maximum age: 82 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by

current or previous diagnostic lesion biopsy

- A Karnofsky performance score > 60

- No previous PUVA treatment

- Anti-ds-DNA (antinuclear antibodies) or anti-Ro/La antibodies: negative

- Acceptable organ function defined as follows:

SGOT (AST) and SGPT (ALT) < 2. 5 times the upper limit of normal for the institution

- Creatinine < 2 times the upper limit of normal for the institution

- No evidence of severe cardiac insufficiency (NYHA grade III-IV)

- Women of child bearing potential must have a negative serum pregnancy test (ß-HCG)

within seven (7) days prior to randomization

- Absence of any serious intercurrent illness or infection at time of entry into the

study that could interfere with planned treatment

- Patients must be willing to accept limiting sun exposure on the day receiving PUVA

treatment

- Written informed consent

Exclusion Criteria:

- Pregnancy and Lactation

- Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome

- Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome

Locations and Contacts

Peter Wolf, MD, Phone: +43 316 385, Ext: 80315, Email: peter.wolf@medunigraz.at

Medical University of Graz, Graz 8010, Austria; Recruiting
Peter Wolf, MD, Phone: +43 316 385, Ext: 80315, Email: peter.wolf@medunigraz.at
Regina Fink-Puches, MD, Phone: +43 316 385, Ext: 12371, Email: regina.fink@medunigraz.at
Peter Wolf, MD, Principal Investigator
Regina Fink-Puches, MD, Sub-Investigator

Department of Dermatology, Medical University of Innsbruck, Innsbruck A-6020, Austria; Not yet recruiting
Gudrun Ratzinger, MD, Phone: +43 512 504, Ext: 81484, Email: gudrun.ratzinger@i-med.ac.at
Matthias Schmuth, MD, Phone: +43 512 504
Matthias Schmuth, MD, Principal Investigator
Gudrun Ratzinger, MD, Sub-Investigator

Department of Dermatology, General Hospital of the City of Linz, Linz A-4021, Austria; Not yet recruiting
Josef Auböck, MD, Phone: +43 732 7806, Ext: 3732, Email: josef.auboeck@akh.linz.at
Christine Scheurecker, MD, Phone: +43 732 7806, Ext: 3732, Email: christine.scheurecker@akh.linz.at
Josef Auböck, MD, Principal Investigator
Christine Scheurecker, MD, Sub-Investigator
Susanne Gross, MD, Sub-Investigator

Department of Dermatology, Hospital Salzburg - Paracelsus Private Medical University, Salzburg A-5020, Austria; Not yet recruiting
Helmut Hintner, MD, Phone: +43 662 4482, Ext: 3001, Email: h.hintner@salk.at
Sylvia Selhofer, MD, Phone: +43 662 4482, Ext: 3001, Email: S.Selhofer@salk.at
Helmut Hintner, MD, Principal Investigator
Sylvia Selhofer, MD, Sub-Investigator

Department of Dermatology, County Hospital St. Pölten, St. Pölten A-3100, Austria; Not yet recruiting
Franz Trautinger, MD, Phone: +43 2742 300, Ext: 11906, Email: franz.trautinger@meduniwien.ac.at
Susanne Eder, MD, Phone: +43 2742 300, Ext: 11906
Franz Trautinger, MD, Principal Investigator
Susanne Eder, MD, Sub-Investigator

Department of Dermatology, Hospital Hietzing, Vienna A-1130, Austria; Not yet recruiting
Paul-Gunther Sator, MD, Phone: +43 1 80110, Ext: 2422, Email: paul.sator@wienkav.at
Andreas Steiner, MD, Phone: +43 1 80110, Ext: 2422
Andreas Steiner, MD, Principal Investigator
Paul-Gunther Sator, MD, Sub-Investigator

Department of Dermatology, Medical University of Vienna, Vienna A-1090, Austria; Not yet recruiting
Adrian Tanew, MD, Phone: +43 1 40400, Ext: 7710, Email: adrian.tanew@meduniwien.ac.at
Anja Pinkowicz, MD, Phone: +43 1 40400, Ext: 7710
Adrian Tanew, MD, Principal Investigator
Anja Pinkowicz, MD, Sub-Investigator

Department of Dermatology, Klinikum Wels, Wels A-4600, Austria; Not yet recruiting
Werner Saxinger, MD, Phone: +43 7242 415, Ext: 9 2105, Email: werner.saxinger@klinikum-wegr.at
Barbara Fleischanderl, MD, Phone: +43 7242 415, Ext: 9 2105
Werner Saxinger, MD, Principal Investigator
Barbara Fleischanderl, MD, Sub-Investigator

Department of Dermatology, County Hospital Wiener Neustadt, Wiener Neustadt A-2700, Austria; Not yet recruiting
Robert Muellegger, MD, Phone: +43 2622 321, Ext: 4901, Email: robert.muellegger@wienerneustadt.lknoe.at
Nicolaus Sandor, MD, Phone: +43 2622 321, Ext: 4901
Robert Muellegger, MD, Principal Investigator
Nicolaus Sandor, MD, Sub-Investigator

Additional Information

Starting date: February 2013
Last updated: June 3, 2015

Page last updated: August 23, 2015

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