Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

Phase 2CompletedNCT00193973

Trans Tasman Radiation Oncology Group20 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Central Nervous System Lymphoma

Interventions

Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-CDRUG

Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.

Radiation TherapyRADIATION

Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (15)

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Prince of Wales Hospital

Outcomes

Primary Outcomes

To estimate the median and 2 year overall survival.

Time frame: Estimate of survival at 2 years and at 5 years.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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