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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00074087
First received: December 10, 2003
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

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 [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Toxicity assessed by CTC v.2.0 at the end of each course [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: October 2003
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caelyx
doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses.
Drug: pegylated liposomal doxorubicin hydrochloride

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074087

Locations
Austria
Karl-Franzens-University Graz
Graz, Austria, A-8010
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, Germany, D-07740
Klinikum der Stadt Mannheim
Mannheim, Germany, D-68135
Klinikum Minden
Minden, Germany, D-32423
Julius Maximilians Universitaet Hospital
Wuerzburg, Germany, D-97080
Israel
Rambam Medical Center
Haifa, Israel, 31096
Italy
Universita di Torino
Turin, Italy, 10126
Switzerland
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
United Kingdom
St. Thomas' Hospital
London, England, United Kingdom, SE1 9RT
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Reinhard Dummer, MD UniversitaetsSpital Zuerich
  More Information

Additional Information:
No publications provided by European Organisation for Research and Treatment of Cancer - EORTC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00074087     History of Changes
Other Study ID Numbers: EORTC-21012, 2004-001746-32
Study First Received: December 10, 2003
Last Updated: January 7, 2013
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014