Clinical trial NCT00193973: Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
Official title: A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma
Keywords: Lymphoma
PCNSL
Primary CNS lymphoma
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: Australasian Leukaemia and Lymphoma Group
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To estimate the median and 2 year overall survival.
timeFrame: Estimate of survival at 2 years and at 5 years.
Secondary outcomes:
measure: Assess acute toxicity.
timeFrame: Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
measure: Assess functional indices of living in patients with PCNSL.
timeFrame: Analysis will be at 5 years.
measure: To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
timeFrame: Analysis at 3 years.
Other outcomes:
Locations:
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Cancer Care Centre
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater QRI
state: Queensland
city: Tugun
country: Australia
facility: Premion - Tugun
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Geelong
country: Australia
facility: Andrew Love Cancer Centre, Geelong Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Newcastle Mater Misericordiae Hospital
name: Peter O'Brien, FRANZCR
role: STUDY_CHAIR
References: