Lymphoma Clinical Trial
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
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.
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.
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