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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Doxorubicin; Liposomal doxorubicin

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