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

NCT00724061 | Terminated Results DMC

• 4 other identifiers: NU 07H4P30CA060553SPRI-NU-07H4STU00002993
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b

  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.

  From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)

• Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM)

  The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.

  During 12 weeks of dose escalation and then up to one year during maintenance therapy.

Secondary Outcomes (2)

• Number of Patients Exhibiting a Complete Response

  During 12 weeks of dose escalation and then up to one year during maintenance therapy.

• To Evaluate the Duration of Response

  At each study visit

Other Outcomes (2)

• Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment

  At baseline and after 2 weeks of treatment (for those patients who consented to this portion)

• Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells

  Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase

Study Arms (1)

PEG-IFN-α-2b + UV therapy

EXPERIMENTAL

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

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

Interventions

Pegylated interferon α-2b BIOLOGICAL

PEG-IFN-α-2b will be administered subcutaneously once a week. The starting dose of PEG-IFN-α-2b will be 1.5μg/kg. Each patient will undergo dose escalation to 3, 4.5, 6, 7.5, and up to 9μg/kg every 2 weeks or to maximum tolerated dose will be allowed. If no dose limiting toxicity (DLT) is observed, the maximum dose reached will be expanded. Once this dose has been given weekly for 2 weeks with no DLT, therapy will continue at this dose for up to 1 year depending on response.

Also known as: PEG-Interferon alfa-2b, PEG-IFN-α-2b, PEG-Intron

PEG-IFN-α-2b + UV therapy

Psoralens with ultraviolet light A OTHER

Oral psoralen (8-methoxypsoralen, 0.6-1.0 mg/kg) will be taken 1.5 to 2 hours prior to UVA treatment. The initial UVA dosage will be approximately 0.5 to 1.5 J/cm2, and will be increased in increments as determined by skin type and tolerability. PUVA therapy will be given 2-3 times per week until complete remission (CR) is achieved. Afterwards, additional maintenance therapy will be given with a gradual reduction from once a week to every 4-6 weeks up to 1 year after CR was achieved.

Also known as: PUVA

PEG-IFN-α-2b + UV therapy

Narrowband-ultraviolet light B OTHER

The initial NB-UVB dose will be 70% of the patient's MED and approximately 0.2 J/cm2 and will be increased by 15% of each subsequent treatment as determined by skin type and/or tolerability. Therapy will be given 3 times per week until complete remission (CR) is achieved. Additional maintenance therapy will be administered while gradually reducing NB-UVB from thrice weekly to once a week. All patients will continue maintenance NB-UVB therapy until 1 year after they have achieved CR.

Also known as: NB-UVB

PEG-IFN-α-2b + UV therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Interventions

peginterferon alfa-2b; Furocoumarins

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Only 7 patients were enrolled before the study was terminated by the Data Monitoring Committee due to poor accrual. Accrual was limited by a worldwide psoralen shortage and well as the exclusion of patients with prior UV light exposure.

Results Point of Contact

• Title: Dr. Timothy Kuzel
• Organization: Northwestern University

cancertrials@northwestern.edu

312-695-6180

Study Officials

• Timothy M. Kuzel, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2008
• First Posted: July 29, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 12, 2018
• Results First Posted: December 2, 2013

Record last verified: 2013-11

Locations

US (1)