Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL

Not Applicable

Terminated

Interventions: Biological: Pegylated interferon α-2b
Other: Psoralens with ultraviolet light A
Other: Narrowband-ultraviolet light B

Brief Summary: 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 is a pilot study of dose-escalating pegylated IFN-α-2b and PUVA or NB-UVB. The purpose is to study the side effects and best dose of PEG-interferon alfa-2b to be given together with ultraviolet light therapy in patients with stage IB, stage II, stage III, or stage IVA mycosis fungoides/Sezary syndrome (CTCL).

Detailed Description: Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive UV light therapy (either PUVA or NB-UVB).

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
PEG-IFN-α-2b + UV therapy	Psoralens with ultraviolet light A	Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
PEG-IFN-α-2b + UV therapy	Narrowband-ultraviolet light B	Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
PEG-IFN-α-2b + UV therapy	Pegylated interferon α-2b	Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).

Primary Outcome Measures

Name	Time	Method
Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b	From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)	Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity.
Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM)	During 12 weeks of dose escalation and then up to one year during maintenance therapy.	The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Exhibiting a Complete Response	During 12 weeks of dose escalation and then up to one year during maintenance therapy.	Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease. CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (\< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR.
To Evaluate the Duration of Response	At each study visit	To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.