Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides

NCT00056056 | Terminated Phase 3 DMC

• 2 other identifiers: EORTC-210112004-003701-24
• Study Type: interventional
• Target: 93
• Locations: 13 countries
• Sites: 28

Brief Summary

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

Lymphoma

Keywords

stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome

Outcome Measures

Primary Outcomes (1)

• Overall response rate (complete clinical response [CCR) and partial response [PR])

  35 months after first patient in

Secondary Outcomes (6)

• Cumulative dose of UVA required to achieve CCR

  35 months after first patient in

• Number of PUVA sessions necessary to achieve a CCR

  35 months after first patient in

• Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression

  35 months after first patient in

• Time to relapse

  35 months after first patient in

• Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks

  35 months after first patient in

Study Arms (2)

Bexarotene and PUVA

EXPERIMENTAL

Drug: bexarotene; Drug: methoxypsoralen; Procedure: UV light therapy

PUVA

ACTIVE COMPARATOR

Drug: methoxypsoralen; Procedure: UV light therapy

Interventions

bexarotene DRUG

The recommended initial dosage of Bexarotene (75 mg Bexarotene capsules to be administered according to body surface area) for patients entered in this trial is 300 mg/m2 /once a day, taken orally, till CCR, PD, unacceptable toxicity, 16 weeks of treatment, whichever comes first

Bexarotene and PUVA

methoxypsoralen DRUG

The dose of methoxypsoralen, as conventional capsules or liquid-filled capsules, is based on the patient's weight. The standard dose of 0.6 mg/kg will be given to all patients three times weekly - Increasing dose of PUVA according to a set protocol after a Minimal Phototoxic Dose (MPD) testing.

Bexarotene and PUVA; PUVA

UV light therapy PROCEDURE

Initial UVA light exposure times should be based on the minimal phototoxic dose (MPD) for the specific light source being used. MPD can be determined by irradiating several skin areas 2 cm in diameter with varying light exposure times and determining the exposure time that produces erythema at 72 hours. The initial dose of UVA administered will be 70% of the MPD. The dose of UVA for the subsequent UVA sessions will be increased according to a standard protocol consisting of 20% increments with each successive treatment session depending on the presence of erythema.

Bexarotene and PUVA; PUVA

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 * 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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (28)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Location

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

Ghent University

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Klinikum der Stadt Mannheim

Mannheim, D-68135, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Hospital Universitario Insular de Gran Canaria

Tübingen, D-72076, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

Würzburg, D-, Germany

Location

Semmelweis University

Budapest, 1085, Hungary

Location

County Hospital

Kaposvár, H-7400, Hungary

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

Location

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Istituto Dermopatico Dell' Immacolata

Rome, 00167, Italy

Location

Universita di Torino

Turin, 10126, Italy

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Nuestra Senora de la Candelaria

Santa Cruz de Tenerife, 38003, Spain

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

St. Thomas' Hospital

London, England, SE1 9RT, United Kingdom

Location

Royal Infirmary of Edinburgh at Little France

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Whittaker 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 DERIVED

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome

Interventions

Bexarotene; Methoxsalen; Ultraviolet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Phototherapy; Therapeutics

Study Officials

• Sean J. Whittaker, MD

  St. Thomas' Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: January 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2011
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

DK (1); FI (1); DE (5); IT (3); ES (5); CH (1); HU (2); AU (2); NL (1); FR (2); GB (2); IL (1); BE (2)