Clinical trial · Interventional
Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy In CTCL
Pilot Study of Pegylated Interferon-Alfa 2b in Combination With PUVA Therapy in Cutaneous T-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed early due to poor accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Narrowband-ultraviolet light B | Other | — | UNRESOLVED |
| Pegylated interferon α-2b | Biological | Peginterferon Alfa-2b | ALIAS |
| Psoralens with ultraviolet light A | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-IFN-α-2b + UV therapy
- description
- Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
- interventionNames
- Biological: Pegylated interferon α-2b
- Other: Psoralens with ultraviolet light A
- Other: Narrowband-ultraviolet light B
Primary outcomes (2)
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
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