Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
NCT ID: NCT00193973
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2001-07-31
2013-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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 Therapy
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
Interventions
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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 Therapy
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who are pregnant or lactating.
* NYHA (New York State Heart Association classification) cardiac failure grade 3
* Macroscopic spinal thecal or spinal cord disease.
18 Years
70 Years
ALL
No
Sponsors
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Australasian Leukaemia and Lymphoma Group
OTHER
Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Peter O'Brien, FRANZCR
Role: STUDY_CHAIR
Newcastle Mater Misericordiae Hospital
Locations
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The Canberra Hospital
Garran, Australian Capital Territory, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Illawarra Cancer Care Centre
Wollongong, New South Wales, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Mater QRI
South Brisbane, Queensland, Australia
Premion - Tugun
Tugun, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Auckland Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Countries
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Related Links
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Click here for more information about this study on the TROG official website
Other Identifiers
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ALLG LY4
Identifier Type: OTHER
Identifier Source: secondary_id
TROG 01.02
Identifier Type: -
Identifier Source: org_study_id
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