Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
- Conditions
- Primary Central Nervous System Lymphoma
- Interventions
- Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-CRadiation: Radiation Therapy
- Registration Number
- NCT00193973
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Radiation Therapy - 1 Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C -
- Primary Outcome Measures
Name Time Method To estimate the median and 2 year overall survival. Estimate of survival at 2 years and at 5 years.
- Secondary Outcome Measures
Name Time Method To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. Analysis at 3 years. Assess acute toxicity. 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. Analysis will be at 5 years.
Trial Locations
- Locations (15)
Calvary Mater Newcastle
🇦🇺Newcastle, New South Wales, Australia
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Premion - Tugun
🇦🇺Tugun, Queensland, Australia
Auckland Hospital
🇳🇿Auckland, New Zealand
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Illawarra Cancer Care Centre
🇦🇺Wollongong, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Royal Brisbane Hospital
🇦🇺Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Mater QRI
🇦🇺South Brisbane, Queensland, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Andrew Love Cancer Centre, Geelong Hospital
🇦🇺Geelong, Victoria, Australia
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia