Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Lymphoma
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
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
Experimental
Caelyx
doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses.