A randomised, open-label phase III trial to evaluate the efficacy and safety of Bexarotene (TargretinTM) capsules combined with PUVA, compared to PUVA treatment alone in patients with Mycosis Fungoides.
- Conditions
- Patients suffering from histopathologically documented Mycosis Fungoides, clinical stage Ib-IIaMedDRA version: 9.1 Level: LLT Classification code 10028500 Term: Mycosis fungoides NOS
- Registration Number
- EUCTR2004-003701-24-DK
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
-Histopathologically documented Mycosis Fungoides, clinical stage Ib-IIa confirmed by current or previous diagnostic lesion biopsy
-A Karnofsky performance = 60
-Age >18 years
-Acceptable organ function defined as follows:
-Hemoglobin = 9 g/dl and WBC = 2 x 1000000000/l
-Bilirubin = 1.5 times the upper limit of normal for the institution
-Creatinine = 2 times the upper limit of normal for the institution
-SGOT (AST) and SGPT (ALT) = 2.5 times the upper limit of normal for the institution
-Serum calcium between LNN for the institution and = 2.8 mmol/l or 11.5 mg/dl
-Fasting serum triglycerides within normal limits for the institution (patients with serum triglycerides that are normalized” prior to study entry with use of an antilidemic agent may be enrolled)
-No evidence of severe cardiac insufficiency, (NYHA grade III-IV)
-Women of child bearing potential must have a negative serum pregnancy test (ß-HCG) within 7 days prior to randomization
-Female patients and male patients with female partners of child bearing potential must agree to practice an effective contraception during the entire period of treatment and for at least 3 months after treatment is discontinued. Female patients with child bearing potential must agree to use a reliable form of contraception. A non-hormonal treatment of contraception is also necessary for women using hormonal contraception methods. Male patients with female sexual partners who are pregnant or potentially pregnant must agree to use condoms during sexual intercourse during the entire period of treatment and for at least 3 months after treatment is discontinued
-No other prior or concurrent primary malignant tumor (except adequately treated in situ carcinoma of the cervix or basal or squamous cell skin carcinoma)
-No prior systemic combination chemotherapy
-TSEB (Total Body Electron Beam) therapy should not have been given less than 6 months before entry into the trial
-Topical chemotherapy, photophoresis and interferon should not have been given less than 3 months before entry into the trial
-No topical medications (corticosteroids or tar baths), UVB/PUVA phototerapy, superficial radiotherapy, treatment with any other retinoid class drugs or beta-carotene compounds within 1 month before entry into the trial
-Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment
-Patients must be willing and able to prolonged exposure to the sun. Patients must be willing to accept limited sun exposure on the day receiving PUVA treatment
-Absence of intrinsic (lupus) or extrinsic (photosensitive drugs) photosensitivity
-Patients must not have participated in any other investigational drug study within 30 days before entry into the trial, or have taken part in any other study of Bexaroten (TargretinTM) capsules
-Absence of any psyciological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
-Before pat
-Lactating women
-Patients who were intolerant or unresponsive to prior PUVA therapy will be excluded
-Patients with known contradiction to Bexarotene (TargretinTM) therapy: known hypersensitivity to retinoids, hypervitaminosis A, patients with prior pancreatitis, excessive alcohol consumption, patients taking drugs associated with pancreatic toxicity or known to increase triglyceride concentrations, patients with uncontrolled diabetes mellitus, uncontrolled thyroid disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Safety data, overall response rates and the duration of response will also be compared.;Primary end point(s): The cumulative dose of UVA necessary to achieve a complete clinical response in both treatment arms (Arm 1: Liquid Psoralen with UVA irradiation (PUVA). Arm 2: Bexarotene (TargretinTM) and PUVA).;Main Objective: To adress whether adding Bexarotene (TargretinTM) to the standard PUVA treatment for patients with stage Ib and IIa Mycosis Fungoides could decrease the cumulative dose of UVA needed to achieve a complete clinical response. The primary objective will therefore be to compare the cumulative dose of UVA required to achieve a CCR in both treatment arms.
- Secondary Outcome Measures
Name Time Method