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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caelyx<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| 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 |  |  | 
| Toxicity assessed by CTC v.2.0 at the end of each course |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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