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

NCT ID: NCT00074087

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-09-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Caelyx

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

Group Type: EXPERIMENTAL

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Interventions

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reinhard Dummer, MD

Role: STUDY_CHAIR

UniversitaetsSpital Zuerich

Locations

Karl-Franzens-University Graz

Graz, , Austria

Allgemeines Krankenhaus - Universitatskliniken

Vienna, , Austria

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

Würzburg, , Germany

Rambam Medical Center

Haifa, , Israel

Universita di Torino

Turin, , Italy

UniversitaetsSpital Zuerich

Zurich, , Switzerland

St. Thomas' Hospital

London, England, United Kingdom

Countries

Austria; Germany; Israel; Italy; Switzerland; United Kingdom

References

Dummer R, Quaglino P, Becker JC, Hasan B, Karrasch M, Whittaker S, Morris S, Weichenthal M, Stadler R, Bagot M, Cozzio A, Bernengo MG, Knobler R. Prospective international multicenter phase II trial of intravenous pegylated liposomal doxorubicin monochemotherapy in patients with stage IIB, IVA, or IVB advanced mycosis fungoides: final results from EORTC 21012. J Clin Oncol. 2012 Nov 20;30(33):4091-7. doi: 10.1200/JCO.2011.39.8065. Epub 2012 Oct 8.

Reference Type: DERIVED

PMID: 23045580 (View on PubMed)

Other Identifiers

2004-001746-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-21012

Identifier Type: -

Identifier Source: org_study_id