Clinical trial NCT00074087 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: pegylated liposomal doxorubicin hydrochloride
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
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