Pilot Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy in Cutaneous T-Cell Lymphoma
- 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
After completion of study therapy, patients are followed for 1 year.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate toxicity
To evaluate toxicity for patients within MF/SS patients with stages IB to IVA
At each study visit
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|