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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin hydrochloride
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage II mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karl-Franzens-University Graz
  • Allgemeines Krankenhaus - Universitatskliniken
  • Universitaetsklinikum Essen
  • Klinikum der Friedrich-Schiller Universitaet Jena
  • Klinikum der Stadt Mannheim
  • Klinikum Minden
  • Julius Maximilians Universitaet Hospital
  • Rambam Medical Center
  • Universita di Torino
  • UniversitaetsSpital Zuerich
  • St. Thomas' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caelyx

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 10, 2003
Last Updated
July 6, 2018
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00074087
Brief Title
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage II mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caelyx
Arm Type
Experimental
Arm Description
doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses.
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Toxicity assessed by CTC v.2.0 at the end of each course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Dummer, MD
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Chair
Facility Information:
Facility Name
Karl-Franzens-University Graz
City
Graz
ZIP/Postal Code
A-8010
Country
Austria
Facility Name
Allgemeines Krankenhaus - Universitatskliniken
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum der Friedrich-Schiller Universitaet Jena
City
Jena
ZIP/Postal Code
D-07740
Country
Germany
Facility Name
Klinikum der Stadt Mannheim
City
Mannheim
ZIP/Postal Code
D-68135
Country
Germany
Facility Name
Klinikum Minden
City
Minden
ZIP/Postal Code
D-32423
Country
Germany
Facility Name
Julius Maximilians Universitaet Hospital
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Universita di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23045580
Citation
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.
Results Reference
derived

Learn more about this trial

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

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