Status:
COMPLETED
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 effective...
Detailed Description
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 recurr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00074087
Start Date
October 1 2003
End Date
September 1 2010
Last Update
July 9 2018
Active Locations (11)
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1
Karl-Franzens-University Graz
Graz, Austria, A-8010
2
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
3
Universitaetsklinikum Essen
Essen, Germany, D-45122
4
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, Germany, D-07740