Completed

Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy

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What is being tested

pegylated liposomal doxorubicin hydrochloride

Drug
Who is being recruted

Bacterial Infections and Mycoses
+11

+ Immune System Diseases
+ Immunoproliferative Disorders
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the antitumor activity of doxorubicin HCl liposome, in terms of response rate (complete response and partial response), in patients with stage IIB, IVA, or IVB recurrent or refractory mycosis fungoides. Secondary * Determine the time to progression and duration of response in patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity or until a maximum cumulative anthracycline(s) dose of 400 mg/m\^2 has been reached (including anthracyclines from prior treatment). Patients are followed every 12 weeks until disease progression. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1 year.

Official TitlePhase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy 
NCT00074087
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
49 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bacterial Infections and Mycoses
Immune System Diseases
Immunoproliferative Disorders
Infections
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Mycoses
Mycosis Fungoides
Neoplasms
Neoplasms by Histologic Type
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed mycosis fungoides * Stage IIB, IVA, or IVB * Refractory or recurrent disease after at least 2 of the following prior therapies: * Local and/or systemic steroids * Retinoids * Interferon alfa * Local carmustine * Systemic chemotherapy * Psoralen and ultraviolet A (PUVA) light therapy * No CNS involvement * No erythroderma (T4) PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * WBC at least 2,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 2.5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * LVEF normal by echocardiography or radionuclide angiocardiography Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 years after study participation * No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up * No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy) * No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 2 weeks since prior immunotherapy Chemotherapy * See Disease Characteristics * Prior systemic chemotherapy allowed provided all of the following conditions are met: * Cumulative anthracycline dose is less than 200 mg/m\^2 * No allergy to anthracyclines * Prior methotrexate is low dose (i.e., weekly dose less than 30 mg) * More than 2 weeks since prior chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent systemic steroids Radiotherapy * More than 2 weeks since prior radiotherapy Surgery * Not specified Other * Recovered from toxic effects of prior therapy, excluding alopecia * No other concurrent anticancer therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses.

Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 11 locations
Suspended
Karl-Franzens-University GrazGraz, AustriaSee the location
Suspended
Allgemeines Krankenhaus - UniversitatsklinikenVienna, Austria
Suspended
Universitaetsklinikum EssenEssen, Germany
Suspended
Klinikum der Friedrich-Schiller Universitaet JenaJena, Germany
Completed11 Study Centers