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


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate toxicity

Outcome Description:

To evaluate toxicity for patients within MF/SS patients with stages IB to IVA

Outcome Time Frame:

At each study visit

Safety Issue:

Yes

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NU 07H4

NCT ID:

NCT00724061

Start Date:

September 2008

Completion Date:

June 2014

Related Keywords:

  • Lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611