Phase II clinical trial with Caelyx mono-chemotherapy in patients with advanced Mycosis fungoides stage IIb, IVa and IVb with or without previous chemotherapy - /

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

- Histopathologically confirmed diagnosis of Mycosis fungoides * stage IIb, IVa, or Ivb
- No CNS involvement and no Erythroderma (T4),
- Refractory or recurrent disease after at least two or more previous therapies(steroids local and/or systemic, retinoids, PUVA, IFN-a, local BCNU, systemic chemotherapy, etc),
- Patients requiring systemic treatment with steroids, for any reason, at the moment of study entry are excluded.
- Prior systemic chemotherapy is allowed if all the following conditions are met:
1. Antracycline cumulative dose <200mg/m2,
2. No allergy to anthracyclines
3. Low dose MTX (weekly dose<30 mg)
- No administration of chemo-, immuno- or radiotherapy within the previous 2 weeks before trial entry. Patients must have completely recovered from all acute toxicities (excluding alopecia).
- Age >18 years,
- Karnofsky performance index = 60
- No other prior or concurrent primary malignant tumor (except adequately treated in situ carcinoma of the cervix uteri or squamos or basal cell skin carcinoma).
- No active infection requiring specific therapy (antibiotics, anti HIV therapy),
- Left ventricular ejection fraction within normal limits (WNL) for each institution measured by echocardiography or by radionuclide angiocardiography,
- Adequate hematologic function (hemoglobin > 10g/dl, WBC >2x109/l, platelets > 75000/mm3, neutrophiles >1.5x109/l),
- Adequate renal and liver functions (serum creatinine and serum bilirubin = 1.5 x the upper limit of normal for the institution and SGOT, SGPT = 2.5 x the upper limit of normal for the institution),
- Female patients potentially childbearing and without effective contraception, pregnant or lactating are excluded. Women of childbearing potential must have a negative pregnancy test within one week before entry into the trial.
- Male patients who agree to practice an effective method of contraception during the entire period of treatment,
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial,
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to determine the antitumor activity of the study treatment for patients with refractory or relapsed advanced stages of mycosis fungoides;Secondary Objective: Secondary objectives are to assess the impact of the trial treatment on the duration of objective response, the time to progression and also to characterize the safety profile of liposomal encapsulated doxorubicin (Caelyx™) in patients with refractory or relapsed advanced stage of mycosis fungoides;Primary end point(s): The primary endpoint is the response rate defined as the proportion of patients who achieve a complete clinical response (CCR) or partial response (PR)

Secondary Outcome Measures

Name	Time	Method

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