Treatment with pimecrolimus cream of early Stage Mycosis Fungoides.
- Conditions
- Patients with Stages Ia-IIa of Mycosis Fungoides.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001377-14-ES
- Lead Sponsor
- Fundación para la Investigación Biomédica del Hospital Universitario 12 de Octubre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Histological diagnosis of Mycosis Fungoides (Stage IA-IIA) confirmed by previous or current biopsy. If the previous biopsy was inconclusive, a confirmatory biopsy must be obtained before entering the study.
Willingness and ability to sign inform consent and sign it up.
Functional status according to the Eastern Cooperative Oncology Group (ECOG) of the subject between 0 and 1 at the screening visit.
Age ? 18 years.
An acceptable organic functional condition defined by certain hematological and biochemical values.
Women of childbearing potential must have a pregnancy test negative seven days before inclusion in the study.
Patients women and men married to women of childbearing potential must use contraception during the entire period of treatment and for one month afterwards. A non-hormonal contraceptive treatment is also necessary for women who use hormonal measures. Men with female partners of childbearing age or pregnant women, patients must use condoms in sexual intercourse during the treatment period.
Breastfeeding women should discontinue nursing prior to treatment initiation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Subjects with a history of other primary malignancies within 5 years prior or concomitant (except in situ cancer, basal cell carcinoma or squamous cell skin carcinoma, adequately treated).
Known or suspected hypersensitivity to treatment with tacrolimus or pimecrolimus.
No previous wash up of at least 1 month of any previous treatment unless patient is in progressive disease. In that case wash up should be at least 2 weeks.
Concurrent treatment for Mycosis Fungoides. Topical or systemic corticosteroids are strictly prohibited. It is not allowed concurrent use of other calcineurin inhibitors.
Patient not fully recovered from toxicity/adverse event secondary to any previous treatment.
Diagnosis of any serious intercurrent illness or infection at the time of entering the study, which may interfere with the study treatment.
Patients who are unable to apply, either by themselves or by their relatives or carers, the study investigational drug in the affected areas.
Known contraindication to pimecrolimus or its excipients.
Patienst must not have participated in another clinical trial in the 30 days prior to entry into this trial nor have participated in any other study with tacrolimus or pimecrolimus.
Diagnosis of active or chronic infection with HIV, HBV or HCV. Absence of any active infection.
Psychological, familial, sociological or geographical condition that may impede compliance with the study protocol and follow-up program, these conditions should be discussed with the patient before inclusion in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of pimecrolimus administered topically as measured by response rate (partial + complete responses) determinated by investigator assessment.;Secondary Objective: Time to response<br>Duration of response <br>Disease-free survival <br>Progression-free survival <br>Safety (Adverse events)<br>Other tumors <br>Objectives of translational research (exploratory), optional;Primary end point(s): Response rate calculated as partial response + complete response per investigator assessment.;Timepoint(s) of evaluation of this end point: Every 4 weeks during treatment period and every 8-12 weeks during the follow-up period.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Time to response<br>Duration of response <br>Disease-free survival <br>Progression-free survival <br>Safety (Adverse events)<br>Other tumors <br>Objectives of translational research (exploratory), optional.<br>Response will be evaluated according to the following criteria:<br>Complete response: 100% clearance of skin lesions.<br>Partial response: 50%-99% clearance of skin disease from baseline withour new tumors.<br>Stable disease: <25% increase to <50% clearance in skin disease from baseline without new tumors.<br>Progressive disease: ?25% increase in skin disease from baseline or new tumors.<br>Relapse: Any disease recurrence in those with complete response.;Timepoint(s) of evaluation of this end point: Every 4 weeks during treatment period and every 8-12 weeks during the follow-up period.