Overview

Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
Male
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-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Treatments:
Methotrexate
Rituximab
Criteria
Inclusion Criteria:

1. age = 18 years.

2. ECOG performance status 0-2

3. Histologically proven primary testicular CD20-positive diffuse large B-cell
non-Hodgkin's lymphoma, untreated

4. 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.

5. Bidimensionally measurable or evaluable disease. Patients who have had all disease
removed by surgery are eligible.

6. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)

7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography

8. No previous therapy with monoclonal antibody anti-CD20.

9. No psychiatric illness that precludes understanding concepts of the trial or signing
informed consent

10. No other major life-threatening illnesses that may preclude chemotherapy

11. 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with the understanding that the consent may be withdrawn by the patient at any time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 Criteria:

1. impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2
mg/dl) unless due to lymphoma involvement

2. HIV positive patients

3. evolutive malignancy within 5 years with the exception of localized non-melanomatous
skin cancer