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Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

Primary Purpose

Primary Central Nervous System Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
Radiation Therapy
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring Lymphoma, PCNSL, Primary CNS lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Canberra Hospital
  • Calvary Mater Newcastle
  • Prince of Wales Hospital
  • Westmead Hospital
  • Illawarra Cancer Care Centre
  • Royal Brisbane Hospital
  • Mater QRI
  • Premion - Tugun
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Andrew Love Cancer Centre, Geelong Hospital
  • Peter MacCallum Cancer Centre
  • Sir Charles Gairdner Hospital
  • Auckland Hospital
  • Christchurch Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To estimate the median and 2 year overall survival.

Secondary Outcome Measures

Assess acute toxicity.
Assess functional indices of living in patients with PCNSL.
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.

Full Information

First Posted
September 13, 2005
Last Updated
February 15, 2017
Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Australasian Leukaemia and Lymphoma Group
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1. Study Identification

Unique Protocol Identification Number
NCT00193973
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
Australasian Leukaemia and Lymphoma Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Central Nervous System Lymphoma
Keywords
Lymphoma, PCNSL, Primary CNS lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
Intervention Description
Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Radiation, Radiotherapy
Intervention Description
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
Primary Outcome Measure Information:
Title
To estimate the median and 2 year overall survival.
Time Frame
Estimate of survival at 2 years and at 5 years.
Secondary Outcome Measure Information:
Title
Assess acute toxicity.
Time Frame
Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
Title
Assess functional indices of living in patients with PCNSL.
Time Frame
Analysis will be at 5 years.
Title
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
Time Frame
Analysis at 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter O'Brien, FRANZCR
Organizational Affiliation
Newcastle Mater Misericordiae Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Illawarra Cancer Care Centre
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater QRI
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Premion - Tugun
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Andrew Love Cancer Centre, Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Auckland Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand

12. IPD Sharing Statement

Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website

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Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

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