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Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00193973
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Australasian Leukaemia and Lymphoma Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date February 17, 2017
Study Start Date  ICMJE July 2001
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2007)
To estimate the median and 2 year overall survival. [ Time Frame: Estimate of survival at 2 years and at 5 years. ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • To estimate the median and 2 year overall survival.
  • To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
Change History Complete list of historical versions of study NCT00193973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2007)
  • Assess acute toxicity. [ Time Frame: Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients. ]
  • Assess functional indices of living in patients with PCNSL. [ Time Frame: Analysis will be at 5 years. ]
  • To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. [ Time Frame: Analysis at 3 years. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Assess acute toxicity.
  • Assess functional indices of living in patients with PCNSL.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
Official Title  ICMJE A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Brief Summary Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.
Detailed Description

Combined modality therapy in PCNSL has improved survival outcomes but at the cost of unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has activity in systemic lymphomas and crosses the blood brain barrier and may add to the efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy survival outcomes should be optimal but with lower rates of neurotoxicity.

Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose radiotherapy and this will allow comparison of survival and neurotoxicity rates.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Central Nervous System Lymphoma
Intervention  ICMJE
  • Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
    Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.
  • Radiation: Radiation Therapy
    Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
    Other Name: Radiation, Radiotherapy
Study Arms  ICMJE Active Comparator: 1
Interventions:
  • Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
  • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2007)
20
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
53
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven primary CNS lymphoma.
  • Absence of disease outside the CNS.
  • ECOG performance status 0-3
  • Negative HIV status.
  • Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L. Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit of normal.
  • Age >18 and <=70 years.
  • Patients must give written informed consent.
  • Corticosteroids prior to histological diagnosis are allowed.

Exclusion Criteria:

  • Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised).
  • Patients who are pregnant or lactating.
  • NYHA (New York State Heart Association classification) cardiac failure grade 3
  • Macroscopic spinal thecal or spinal cord disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00193973
Other Study ID Numbers  ICMJE TROG 01.02
ALLG LY4 ( Other Identifier: ALLG )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trans-Tasman Radiation Oncology Group (TROG)
Study Sponsor  ICMJE Trans-Tasman Radiation Oncology Group (TROG)
Collaborators  ICMJE Australasian Leukaemia and Lymphoma Group
Investigators  ICMJE
Study Chair: Peter O'Brien, FRANZCR Newcastle Mater Misericordiae Hospital
PRS Account Trans-Tasman Radiation Oncology Group (TROG)
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP