Clinical Trial: PUVA Maintenance Therapy in Mycosis Fungoides

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 PU
Sponsor: Medical University of Graz

Current Primary Outcome: Recurrence after complete remission within 12 months post therapy [ Time Frame: 12 months after end of therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of life [ Time Frame: Week -4 to 0; week 12, 24, 36, and 48; month 15, 18, 21, 24, 36, 48, 60, and 72 ]
  Compared to baseline
• HADS [ Time Frame: Week -4 to 0; week 12, 24, 36, and 48; month 15, 18, 21, 24, 36, 48, 60, and 72 ]
  Hospital anxiety depression score, compared to baseline;
• Cytokine response in serum [ Time Frame: Week -4 to 0; week 6, 12, 24, and 48 ]
  Compared to baseline
• Levels of regulatory T cells [ Time Frame: Week -4 to 0; week 6, 12, 24, and 48 ]
  Compared to baseline
• Function of regulatory T cells [ Time Frame: Week -4 to 0; week 6, 12, 24, and 48 ]
  Compared to baseline
• Microscopic alterations [ Time Frame: Week -4 to 0; and week 6; optional at week 12, 24, and 48; and in the follow-up from year 1 to 5 ]
  Quantification of histologic response in skin biopsy
• Cytokine expression in the skin [ Time Frame: Week -4 to 0; and week 6; optional at week 12, 24, and 48; and in the follow-up from year 1 to 5 ]
  Rt-PCR and immunohistochemical staining investigations

Original Secondary Outcome: Same as current

Information By: Medical University of Graz

Dates:
Date Received: May 9, 2012
Date Started: February 2013
Date Completion: October 2022
Last Updated: January 11, 2017
Last Verified: January 2017