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Salvage Therapy With Idarubicin in Relapsing CNS 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: NCT00210366
  Purpose

The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.


Condition Intervention Phase
Lymphoma, B-Cell
Drug: Idarubicin
Phase II

MedlinePlus related topics: Lymphoma
Drug Information available for: Idarubicin Idarubicin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas

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

Primary Outcome Measures:
  • objective response to treatment

Secondary Outcome Measures:
  • duration of response
  • overall survival
  • acute side effects of idarubicin

Estimated Enrollment: 25
Study Start Date: March 2004
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of non-Hodgkin's lymphoma
  • Disease exclusively localised into the CNS at first diagnosis and failure
  • Progressive or recurrent disease
  • Previous treatment with HDMTX containing CHT and/or RT
  • Presence of at least one target lesion, bidimensionally measurable
  • Age 18 - 75 years
  • ECOG performance status < 3 (Appendix 1).
  • No known HIV disease or immunodeficiency
  • HBsAg-negative and Ab anti-HCV-negative patients.
  • Adequate bone marrow function (plt > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3)
  • Adequate renal function (serum creatinine < 2 times UNL)
  • Adequate hepatic function (SGOT/SGPT < 3 times UNL, bilirubin and alkaline phosphatase < 2 times UNL)
  • Adequate cardiac function (VEF ≥ 50%)
  • Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
  • No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
  • No concurrent treatment with other experimental drugs.
  • Informed consent signed by the patient before registration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210366

Contacts
Contact: Andres JM Ferreri, MD +39 02 2643 ext 7649 ferreri.andres@hsr.it

Locations
Italy
Servizio Radiochemioterapia - Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Andres JM Ferreri     +39 022643 ext 7649     andres.ferreri@hsr.it    
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
Study Chair: Andres JM Ferreri, MD San Raffaele Hospital - HSR Servizio di radiochemioterapia
  More Information

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

Study ID Numbers: IELSG21
Study First Received: September 13, 2005
Last Updated: October 16, 2006
ClinicalTrials.gov Identifier: NCT00210366  
Health Authority: Italy: Ministry of Health

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Idarubicin
Immunoproliferative Disorders
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Central nervous system lymphoma, primary

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009