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

This study is currently recruiting participants.
Verified by International Extranodal Lymphoma Study Group (IELSG), September 2005

Sponsored by: International Extranodal Lymphoma Study Group (IELSG)
Information provided by: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT00210379
  Purpose

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


Condition Intervention Phase
Lymphoma, B Cell
Drug: rituximab
Drug: CHOP
Drug: intrathecal methotrexate
Procedure: radiotherapy
Phase II

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Methotrexate    Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin’s Lymphoma

Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • Disease-free survival
  • Progression-free survival
  • Event-free survival

Secondary Outcome Measures:
  • Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable

Estimated Enrollment:   50
Study Start Date:   November 2000

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210379

Contacts
Contact: Cristina Morinini     +41 91 8119040     ielsg@ticino.com    

Locations
Switzerland
Oncology Institute of Southern Switzerland (IOSI)     Recruiting
      Bellinzona, Switzerland, 6500
      Contact: Cristina Morinini     +41 91 8119040     ielsg@ticino.com    

Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)

Investigators
Study Chair:     Andreas Sarris, MD     International Extranodal Lymphoma Study Group    
Study Chair:     Emanuele Zucca, MD     International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)    
Study Chair:     Mary Gospodarowicz, MD     Radiation Oncology. Princess Margareth Hospital. Toronto    
Study Chair:     Umberto Vitolo, MD     Hematology Division. Ospedale San Giovanni Battista. Torino    
  More Information


Click here for more information about this study  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   IELSG10
First Received:   September 13, 2005
Last Updated:   September 13, 2005
ClinicalTrials.gov Identifier:   NCT00210379
Health Authority:   Switzerland: Swissmedic

Study placed in the following topic categories:
Folic Acid
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse
Methotrexate
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 03, 2008




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