A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
18 Years
70 Years
Both
Primary Central Nervous System Lymphoma
Trial Information
A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To estimate the median and 2 year overall survival.
Outcome Time Frame:
Estimate of survival at 2 years and at 5 years.
Safety Issue:
No
Principal Investigator
Peter O'Brien, FRANZCR
Investigator Role:
Study Chair
Investigator Affiliation:
Newcastle Mater Misericordiae Hospital
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
TROG 01.02
NCT ID:
NCT00193973
Start Date:
July 2001
Completion Date:
July 2009
Related Keywords:
- Primary Central Nervous System Lymphoma
- Lymphoma
- PCNSL
- Primary CNS lymphoma
- Lymphoma
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