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
18 Years
N/A
Both
Lymphoma
Trial Information
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
OBJECTIVES:
- Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without
bexarotene yields a significantly higher overall response rate in patients with mycosis
fungoides.
- Compare the overall response rate (CCR and partial response) in patients treated with
these regimens.
- Compare the duration of CCR and time to relapse of patients treated with these
regimens.
- Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
- Determine the percentage of dropouts by patients treated with these regimens.
- Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, age (60 and under vs over 60), and stage of disease (IB
vs IIA). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole
body ultraviolet A therapy. PUVA is given 3 times per week.
- Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms,
treatment repeats for up to 16 weeks in the absence of complete clinical response,
disease progression, or unacceptable toxicity.
Patients are followed every 8 weeks until the first documented progression or relapse.
PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 25 months.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (complete clinical response [CCR) and partial response [PR])
Outcome Time Frame:
35 months after first patient in
Safety Issue:
No
Principal Investigator
Sean J. Whittaker, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Thomas' Hospital
Authority:
Switzerland: Swissmedic
Study ID:
EORTC-21011
NCT ID:
NCT00056056
Start Date:
January 2003
Completion Date:
June 2011
Related Keywords:
- Lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- Lymphoma
- Mycoses
- Mycosis Fungoides
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