Status:
COMPLETED
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Australasian Leukaemia and Lymphoma Group
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 d...
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 lympho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00193973
Start Date
July 1 2001
End Date
August 1 2013
Last Update
February 17 2017
Active Locations (15)
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1
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
4
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145