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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

Phase 3
18 Years
Not Enrolling

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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


- Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without
bexarotene yields a significantly higher overall response rate in patients with mycosis

- 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

- 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


- Histologically confirmed mycosis fungoides

- Stage IB or IIA

- Confirmed by current or prior diagnostic lesion biopsy



- Over 18

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified


- WBC at least 2,000/mm^3

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN


- Creatinine no greater than 2 times ULN

- Calcium no greater than 11.5 mg/dL


- No New York Heart Association grade III or IV cardiac insufficiency


- 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

- 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

- 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


Biologic therapy

- At least 3 months since prior interferon therapy


- 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


- At least 6 months since prior total skin electron beam therapy

- At least 1 month since prior superficial radiotherapy


- Not specified


- 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:


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:


Principal Investigator

Sean J. Whittaker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Thomas' Hospital


Switzerland: Swissmedic

Study ID:




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