Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Sean J. Whittaker

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00056056
Information obtained from ClinicalTrials.gov on December 20, 2011

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