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Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Sponsor
International Extranodal Lymphoma Study Group (IELSG) (Other)
Overall Status
Terminated
CT.gov ID
NCT00210366
Collaborator
(none)
25
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Jul 1, 2010

Outcome Measures

Primary Outcome Measures

  1. objective response to treatment []

Secondary Outcome Measures

  1. duration of response []

  2. overall survival []

  3. acute side effects of idarubicin []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Servizio Radiochemioterapia - Ospedale San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • International Extranodal Lymphoma Study Group (IELSG)

Investigators

  • Study Chair: Andres JM Ferreri, MD, San Raffaele Hospital - HSR Servizio di radiochemioterapia

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00210366
Other Study ID Numbers:
  • IELSG21
First Posted:
Sep 21, 2005
Last Update Posted:
Jul 30, 2010
Last Verified:
Jul 1, 2010
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Idarubicin

Study Results

No Results Posted as of Jul 30, 2010