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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074087 |
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 II |
MedlinePlus related topics: | Cancer Fungal Infections Lymphoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | October 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mycosis fungoides
Refractory or recurrent disease after at least 2 of the following prior therapies:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Prior systemic chemotherapy allowed provided all of the following conditions are met:
Endocrine therapy
Radiotherapy
Surgery
Other
Austria | |||||
Allgemeines Krankenhaus - Universitatskliniken | Recruiting | ||||
Vienna, Austria, A-1090 | |||||
Contact: Contact Person 43-1-40-400 | |||||
Karl-Franzens-University Graz | Recruiting | ||||
Graz, Austria, A-8010 | |||||
Contact: Contact Person 43-316-380-4100 | |||||
Germany | |||||
Julius Maximilians Universitaet Hospital | Recruiting | ||||
Wuerzburg, Germany, D-97080 | |||||
Contact: Contact Person 49-9-312-012-3756 | |||||
Klinikum der Stadt Mannheim | Recruiting | ||||
Mannheim, Germany, D-68135 | |||||
Contact: Contact Person 49-621-383-3833 | |||||
Klinikum Minden | Recruiting | ||||
Minden, Germany, D-32423 | |||||
Contact: Contact Person 49-571-801-4810 | |||||
Universitaetsklinikum Essen | Recruiting | ||||
Essen, Germany, D-45122 | |||||
Contact: Contact Person 49-201-723-2321 | |||||
Italy | |||||
Universita di Torino | Recruiting | ||||
Turin, Italy, 10126 | |||||
Contact: Contact Person 39-011-670-5955 | |||||
Switzerland | |||||
UniversitaetsSpital Zuerich | Recruiting | ||||
Zurich, Switzerland, CH-8091 | |||||
Contact: Contact Person 41-1-255-1111 | |||||
United Kingdom, England | |||||
St. Thomas' Hospital | Recruiting | ||||
London, England, United Kingdom, SE1 9RT | |||||
Contact: Contact Person 44-171-922-8009 |
European Organization for Research and Treatment of Cancer |
Investigator: | Reinhard Dummer, MD | UniversitaetsSpital Zuerich |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000341686, EORTC-21012, EUDRACT-2004-001746-32 |
First Received: | December 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00074087 |
Health Authority: | Unspecified |
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