Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193973
• Other study ID #: TROG 01.02
• Secondary ID: ALLG LY4
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 15, 2017
• Start date: July 2001
• Est. completion date: August 2013

Study information

• Verified date: February 2017
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

Drug:
• 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:
• Radiation Therapy
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Andrew Love Cancer Centre, Geelong Hospital	Geelong	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater QRI	South Brisbane	Queensland
Australia	Premion - Tugun	Tugun	Queensland
Australia	Westmead Hospital	Wentworthville	New South Wales
Australia	Illawarra Cancer Care Centre	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Auckland Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Australasian Leukaemia and Lymphoma Group

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the median and 2 year overall survival.		Estimate of survival at 2 years and at 5 years.
Secondary	Assess acute toxicity.		Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
Secondary	Assess functional indices of living in patients with PCNSL.		Analysis will be at 5 years.
Secondary	To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.		Analysis at 3 years.

External Links

•   Click here for more information about this study on the TROG official website