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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074087
• Other study ID #: EORTC-21012
• Secondary ID: 2004-001746-32
• Status: Completed
• Phase: Phase 2
• Start date: October 2003
• Est. completion date: September 2010

Study information

• Verified date: July 2018
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
Austria	Karl-Franzens-University Graz	Graz
Austria	Allgemeines Krankenhaus - Universitatskliniken	Vienna
Germany	Universitaetsklinikum Essen	Essen
Germany	Klinikum der Friedrich-Schiller Universitaet Jena	Jena
Germany	Klinikum der Stadt Mannheim	Mannheim
Germany	Klinikum Minden	Minden
Germany	Julius Maximilians Universitaet Hospital	Wuerzburg
Israel	Rambam Medical Center	Haifa
Italy	Universita di Torino	Turin
Switzerland	UniversitaetsSpital Zuerich	Zurich
United Kingdom	St. Thomas' Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Germany,  Israel,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Toxicity assessed by CTC v.2.0 at the end of each course