Clinical trial · Interventional
Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides
NCT00056056CI-TRIAL-00033670terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides. PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.
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 |
|---|---|---|---|
| bexarotene | Drug | Bexarotene | ALIAS |
| methoxypsoralen | Drug | — | UNRESOLVED |
| UV light therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bexarotene and PUVA
- interventionNames
- Drug: bexarotene
- Drug: methoxypsoralen
- Procedure: UV light therapy
- type
- ACTIVE_COMPARATOR
- label
- PUVA
- interventionNames
- Drug: methoxypsoralen
- Procedure: UV light therapy
Primary outcomes (1)
- measure
- Overall response rate (complete clinical response [CCR) and partial response [PR])
- timeFrame
- 35 months after first patient in
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed mycosis fungoides * Stage IB or IIA * Confirmed by current or prior diagnostic lesion biopsy PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * WBC at least 2,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN Renal * Creatinine no greater than 2 times ULN * Calcium no greater than 11.5 mg/dL Cardiovascular * No New York Heart Association grade III or IV cardiac insufficiency Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation\* NOTE: \*Women using hormonal contraception must also use a non-hormonal treatment * Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization) * Willing and able to avoid prolonged exposure to the sun * Willing to limit sun exposure on day of PUVA therapy * No prior intolerance of or unresponsiveness to PUVA therapy * No other prior or concurrent malignant tumor except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No prior pancreatitis * No other concurrent serious illness or infection that would preclude study participation * No concurrent excessive alcohol consumption * No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive drugs) factors * No psychological, familial, sociological, or geographical condition that would preclude study compliance * No known contraindications to study drug * No known hypersensitivity to retinoids or hypervitaminosis A * No uncontrolled diabetes mellitus * No uncontrolled thyroid disease PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 months since prior interferon therapy Chemotherapy * No prior systemic combination chemotherapy * No prior participation in another study of bexarotene * At least 3 months since prior topical chemotherapy Endocrine therapy * At least 1 month since prior topical corticosteroids Radiotherapy * At least 6 months since prior total skin electron beam therapy * At least 1 month since prior superficial radiotherapy Surgery * Not specified Other * At least 30 days since prior participation in another investigational drug study * At least 3 months since prior photopheresis * At least 1 month since prior UVB/PUVA phototherapy * At least 1 month since prior retinoid class drugs * At least 1 month since prior beta-carotene compounds * At least 1 month since other prior topical medications (e.g., tar baths) * No prior participation in this study * No other concurrent anticancer therapy * No other concurrent investigational drug therapy * No concurrent drugs associated with pancreatic toxicity or known to increase triglyceride concentrations
References
Publications (1)
- DERIVEDWhittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. doi: 10.1111/j.1365-2133.2012.11156.x. PMID 22924950