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

Northwestern University

Status: Terminated

Conditions: Lymphoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00724061

P30CA060553 (U.S. NIH Grant/Contract)

NU 07H4 (Other Identifier)

STU00002993 (Other Identifier)

SPRI-NU-07H4

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

PEG-IFN-α-2b + UV therapy

Experimental group

Description:

Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).

Treatment:

Biological: Pegylated interferon α-2b

Other: Narrowband-ultraviolet light B

Other: Psoralens with ultraviolet light A