Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||October 2003|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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|
- 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.
- 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.
|Graz, Austria, A-8010|
|Allgemeines Krankenhaus - Universitatskliniken|
|Vienna, Austria, A-1090|
|Essen, Germany, D-45122|
|Klinikum der Friedrich-Schiller Universitaet Jena|
|Jena, Germany, D-07740|
|Klinikum der Stadt Mannheim|
|Mannheim, Germany, D-68135|
|Minden, Germany, D-32423|
|Julius Maximilians Universitaet Hospital|
|Wuerzburg, Germany, D-97080|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Universita di Torino|
|Turin, Italy, 10126|
|Zurich, Switzerland, CH-8091|
|St. Thomas' Hospital|
|London, England, United Kingdom, SE1 9RT|
|Study Chair:||Reinhard Dummer, MD||UniversitaetsSpital Zuerich|