Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

February 15, 2017 updated by: Trans Tasman Radiation Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
      • Wollongong, New South Wales, Australia
        • Illawarra Cancer Care Centre
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater QRI
      • Tugun, Queensland, Australia, 4224
        • Premion - Tugun
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Centre, Geelong Hospital
      • Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • New Zealand
      • Auckland, New Zealand, 1001
        • Auckland Hospital
      • Christchurch, New Zealand, 4710
        • Christchurch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
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
Other Names:
  • Radiation, Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate the median and 2 year overall survival.
Time Frame: Estimate of survival at 2 years and at 5 years.
Estimate of survival at 2 years and at 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess acute toxicity.
Time Frame: Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
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.
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.
Analysis at 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

Australasian Leukaemia and Lymphoma Group

Investigators

  • Study Chair: Peter O'Brien, FRANZCR, Newcastle Mater Misericordiae Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 01.02
  • ALLG LY4 (OTHER: ALLG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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