Clinical trial NCT00724061: Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL
Official title: Pilot Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy in Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b
timeFrame: From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)
measure: Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM)
timeFrame: During 12 weeks of dose escalation and then up to one year during maintenance therapy.
Secondary outcomes:
measure: Number of Patients Exhibiting a Complete Response
timeFrame: During 12 weeks of dose escalation and then up to one year during maintenance therapy.
measure: To Evaluate the Duration of Response
timeFrame: At each study visit
Other outcomes:
measure: Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment
timeFrame: At baseline and after 2 weeks of treatment (for those patients who consented to this portion)
measure: Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells
timeFrame: Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Timothy M. Kuzel, MD
role: PRINCIPAL_INVESTIGATOR
References: