Clinical Trial: Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.


Detailed Summary:

OBJECTIVES:

  • Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene yields a significantly higher overall response rate in patients with mycosis fungoides.
  • Compare the overall response rate (CCR and partial response) in patients treated with these regimens.
  • Compare the duration of CCR and time to relapse of patients treated with these regimens.
  • Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
  • Determine the percentage of dropouts by patients treated with these regimens.
  • Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and stage of disease (IB vs IIA). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week.
  • Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity.

Patients are followed every 8 weeks until the first documented progression or relapse.

PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 25 months.


Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: Overall response rate (complete clinical response [CCR) and partial response [PR]) [ Time Frame: 35 months after first patient in ]

Original Primary Outcome:

Current Secondary Outcome:

  • Cumulative dose of UVA required to achieve CCR [ Time Frame: 35 months after first patient in ]
  • Number of PUVA sessions necessary to achieve a CCR [ Time Frame: 35 months after first patient in ]
  • Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression [ Time Frame: 35 months after first patient in ]
  • Time to relapse [ Time Frame: 35 months after first patient in ]
  • Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks [ Time Frame: 35 months after first patient in ]
  • Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment [ Time Frame: 35 months after first patient in ]


Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: March 6, 2003
Date Started: January 2003
Date Completion:
Last Updated: June 19, 2012
Last Verified: June 2012