Primary Central Nervous System LymphomaPhase 2NCT00193973
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
A Phase 2 study testing Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C and Radiation Therapy in people with Primary Central Nervous System Lymphoma, run by Trans Tasman Radiation Oncology Group at 15 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jul 2001to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Australia13 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, 3220
Royal Brisbane Hospital
Herston, Queensland, 4029
Peter MacCallum Cancer Centre
Melbourne, Victoria, 8006
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Prince of Wales Hospital
Randwick, New South Wales, 2031
Mater QRI
South Brisbane, Queensland, 4101
Premion - Tugun
Tugun, Queensland, 4224
Westmead Hospital
Wentworthville, New South Wales, 2145
Illawarra Cancer Care Centre
Wollongong, New South Wales
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand2 sites
Auckland Hospital
Auckland, 1001
Christchurch Hospital
Christchurch, 4710
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C, Radiation Therapy
- Keywords
- Lymphoma, PCNSL, Primary CNS lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Radiation TherapyRadiation
Also called Radiation, Radiotherapy
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the median and 2 year overall survival.
Measured: Estimate of survival at 2 years and at 5 years.
Secondary outcomes (3)
Assess acute toxicity.
Measured: 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.
Measured: Analysis will be at 5 years.
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
Measured: Analysis at 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2001
- Primary completionJul 2008
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Leukaemia and Lymphoma Group
- Responsible party
- Sponsor
- Investigators
- Peter O'Brien, FRANZCR, Study chair, Newcastle Mater Misericordiae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193973
- Sponsor's protocol ID
- TROG 01.02
- Other IDs
- ALLG LY4
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT00193973
- Acronym / sponsor ID
- TROG 01.02
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- Lymphoma, PCNSL, Primary CNS lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Australasian Leukaemia and Lymphoma Group
- Study start
- Jul 2001
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C, Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-CIdarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50. | Drug | 1 |
| Radiation TherapyAlso: Radiation, RadiotherapyWhole brain Irradiation, 30Gy in 20 fractions over 4 weeks | Radiation | 1 |
Primary outcome
To estimate the median and 2 year overall survival.
Time frame: Estimate of survival at 2 years and at 5 years.
3 secondary outcomes
Assess acute toxicity.
Time frame: 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.
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
Time frame: Analysis at 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter O'Brien, FRANZCR study chair
Newcastle Mater Misericordiae Hospital
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C and Radiation Therapy in people with Primary Central Nervous System Lymphoma, run by Trans Tasman Radiation Oncology Group at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the median and 2 year overall survival. (time frame: Estimate of survival at 2 years and at 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.