Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb, IVa and IVb With or Without Previous Chemotherapy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Reinhard Dummer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UniversitaetsSpital Zuerich
Authority:
United States: Federal Government
Study ID:
EORTC-21012
NCT ID:
NCT00074087
Start Date:
October 2003
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Mycoses
- Mycosis Fungoides
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