Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: pegylated liposomal doxorubicin hydrochloride

• Registration Number: NCT00074087
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis fungoides.

Detailed Description

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-12-10
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Primary Completion: 2009-07
• Study Completion: 2010-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caelyx	pegylated liposomal doxorubicin hydrochloride	doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses.

Primary Outcome Measures

Name	Time	Method
Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression

Secondary Outcome Measures

Name	Time	Method
Time to progression measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment
Duration of response measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment and then every 12 weeks until progression
Toxicity assessed by CTC v.2.0 at the end of each course

Trial Locations

Locations (11)

Karl-Franzens-University Graz; 🇦🇹 Graz, Austria

St. Thomas' Hospital; 🇬🇧 London, England, United Kingdom

Allgemeines Krankenhaus - Universitatskliniken; 🇦🇹 Vienna, Austria

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Julius Maximilians Universitaet Hospital; 🇩🇪 Wuerzburg, Germany

Klinikum der Friedrich-Schiller Universitaet Jena; 🇩🇪 Jena, Germany

Klinikum der Stadt Mannheim; 🇩🇪 Mannheim, Germany

Klinikum Minden; 🇩🇪 Minden, Germany

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

Universita di Torino; 🇮🇹 Turin, Italy

Rambam Medical Center; 🇮🇱 Haifa, Israel