Status:
COMPLETED
Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma
Lead Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Conditions:
Lymphoma, B Cell
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco...
Eligibility Criteria
Inclusion
- age = 18 years.
- ECOG performance status 0-2
- Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
- Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
- Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
- Adequate bone marrow reserve (ANC \> 1.000/L, Plt \> 100.000/L)
- Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
- No previous therapy with monoclonal antibody anti-CD20.
- No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- No other major life-threatening illnesses that may preclude chemotherapy
- Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice
Exclusion
- impairment of renal function (creatinine \> 2 mg/dl) or liver function (bilirubin \> 2 mg/dl) unless due to lymphoma involvement
- HIV positive patients
- evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00210379
Start Date
November 1 2000
End Date
March 1 2007
Last Update
July 22 2009
Active Locations (1)
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1
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500