Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy
- 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.
- Determine the time to progression and duration of response in patients treated with
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Reinhard Dummer, MD
United States: Federal Government