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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

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00724061
First received: July 26, 2008
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Lymphoma
 Biological: PEG-interferon alfa-2b
Procedure: UV light therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy in Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To evaluate toxicity [ Time Frame: At each study visit ] [ Designated as safety issue: Yes ]
    To evaluate toxicity for patients within MF/SS patients with stages IB to IVA


Secondary Outcome Measures:
  • To evaluate efficacy [ Time Frame: At each study visit ] [ Designated as safety issue: No ]
    To evaluate efficacy related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.

  • To evaluate the duration of response [ Time Frame: At each study visit ] [ Designated as safety issue: Yes ]
    To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.


Enrollment: 7
Study Start Date: September 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: PEG-interferon alfa-2b
    PEG-IFN-α-2b will be administered subcutaneously once weekly in an outpatient clinic or at home by self-administration or a trained family member.
    Procedure: UV light therapy
    Oral psoralen (8-methoxypsoralen, 0.6-1.0 mg/kg) will be taken 1.5 to 2 hours prior to UVA treatment as previously described by Querfeld et al.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724061

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00724061     History of Changes
Other Study ID Numbers: NU 07H4, P30CA060553, NU-07H4, SPRI-NU-07H4, STU00002993
Study First Received: July 26, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Lymphoma
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
 Interferons
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on June 18, 2013