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

Condition(s) targeted: Lymphoma

Intervention: PEG-interferon alfa-2b (Biological); UV light therapy (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Timothy M. Kuzel, MD, Principal Investigator, Affiliation: Robert H. Lurie Cancer Center

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.

Official title: Pilot Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy in Cutaneous T-Cell Lymphoma

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate toxicity

Secondary outcome:

To evaluate efficacy

To evaluate the duration of response

Detailed description: OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed mycosis fungoides/Sezary syndrome

- Stage IB-IVA disease

- Erythrodermic disease allowed

- Measurable disease

- One or more indicatory lesions must be designated prior to study entry

PATIENT CHARACTERISTICS:

- ECOG/WHO performance status 0-1

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 75,000/mm³

- WBC ≥ 3,000/mm³

- Serum creatinine ≤ 2. 0 mg/dL

- Total serum bilirubin ≤ 2. 2 mg/dL

- Serum AST and ALT ≤ 2 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients must be disease free of prior malignancies for ≥ 5 years except currently

treated squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision

- No history of seizure disorder or severe heart disease

- No acute infections

- Diagnosed depression allowed with receiving appropriate care for depression

PRIOR CONCURRENT THERAPY:

- No prior psoralens with ultraviolet light A or interferon alfa therapy

- More than 4 weeks since prior topical therapy, systemic chemotherapy, or biologic

therapy

- More than 4 weeks since prior surgery and fully recovered

- At least 1 week since prior antibiotics

- No other concurrent standard or investigational topical and systemic antipsoriatic or

anticancer therapies including radiation, steroids, retinoids, nitrogen mustard, thalidomide, or other investigational agents

- No concurrent topical agents except emollients

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois 60611-3013, United States; Recruiting
Clinical Trials Office - Robert H. Lurie Comprehensive Cancer, Phone: 312-695-1301, Email: cancer@northwestern.edu

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2008
Last updated: October 18, 2011