NCT00193973

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_2

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

7 years

First QC Date

September 13, 2005

Last Update Submit

February 15, 2017

Conditions

Primary Central Nervous System Lymphoma

Keywords

LymphomaPCNSLPrimary CNS lymphoma

Outcome Measures

Primary Outcomes (1)

  • To estimate the median and 2 year overall survival.

    Estimate of survival at 2 years and at 5 years.

Secondary Outcomes (3)

  • Assess acute toxicity.

    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.

    Analysis will be at 5 years.

  • To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.

    Analysis at 3 years.

Study Arms (1)

1

ACTIVE COMPARATOR
Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-CRadiation: Radiation Therapy

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.

1
Radiation TherapyRADIATION

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

Also known as: Radiation, Radiotherapy
1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Illawarra Cancer Care Centre

Wollongong, New South Wales, Australia

Location

Royal Brisbane Hospital

Herston, Queensland, 4029, Australia

Location

Mater QRI

South Brisbane, Queensland, 4101, Australia

Location

Premion - Tugun

Tugun, Queensland, 4224, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Andrew Love Cancer Centre, Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Auckland Hospital

Auckland, 1001, New Zealand

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

Related Links

MeSH Terms

Conditions

Lymphoma

Interventions

IdarubicinMethotrexateFilgrastimRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTherapeuticsPhysical Phenomena

Study Officials

  • Peter O'Brien, FRANZCR

    Newcastle Mater Misericordiae Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

July 1, 2001

Primary Completion

July 1, 2008

Study Completion

August 1, 2013

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

NZ(2)AU(13)