PEG-Interferon Alfa-2b and Ultraviolet Light Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Mycosis Fungoides/Sezary Syndrome
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of mycosis fungoides/Sezary syndrome. Ultraviolet light therapy uses a drug, such as psoralen, that is absorbed by cancer cells. The drug becomes active when it is exposed to ultraviolet light. When the drug is active, cancer cells are killed. Giving PEG-interferon alfa-2b together with ultraviolet light therapy may kill more cancer cell.
PURPOSE: This clinical trial is studying the side effects and best dose of PEG-interferon alfa-2b when given together with ultraviolet light therapy in treating patients with stage IB, stage II, stage III, or stage IVA mycosis fungoides/Sezary syndrome.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy in Cutaneous T-Cell Lymphoma|
- To evaluate toxicity [ Time Frame: At each study visit ] [ Designated as safety issue: Yes ]To evaluate toxicity for patients within MF/SS patients with stages IB to IVA
- To evaluate efficacy [ Time Frame: At each study visit ] [ Designated as safety issue: No ]To evaluate efficacy related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.
- To evaluate the duration of response [ Time Frame: At each study visit ] [ Designated as safety issue: Yes ]To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Biological: PEG-interferon alfa-2b
- To evaluate toxicity, patient self-reported disease and treatment-related symptoms, and the impact of treatment on quality of life of combined pegylated interferon alfa-2b (IFN-α-2b) and psoralens with ultraviolet light A (PUVA) therapy on health-related quality of life in patients with stages IB-IVA mycosis fungoides/Sezary syndrome.
- To evaluate efficacy and duration of response related to combined pegylated IFN-α-2b plus PUVA therapy in these patients.
OUTLINE: This is an intrapatient dose-escalation study of PEG-interferon alfa-2b.
Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive oral psoralen 1.5-2 hours prior to ultraviolet light A treatment. Treatment with UV light therapy repeats 2-3 times weekly until complete remission is achieved and then once every 4-6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Health-related quality of life is assessed periodically using the FACT-BRM, FACT-G, and FACT-CTCL questionnaires.
After completion of study therapy, patients are followed for 1 year.
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Principal Investigator:||Timothy M. Kuzel, MD||Robert H. Lurie Cancer Center|