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Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193973
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 17, 2017
Australasian Leukaemia and Lymphoma Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)

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.

Condition or disease Intervention/treatment Phase
Primary Central Nervous System Lymphoma Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C Radiation: Radiation Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Study Start Date : July 2001
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2013

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 Name: Radiation, Radiotherapy

Primary Outcome Measures :
  1. To estimate the median and 2 year overall survival. [ Time Frame: Estimate of survival at 2 years and at 5 years. ]

Secondary Outcome Measures :
  1. Assess acute toxicity. [ Time Frame: Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients. ]
  2. Assess functional indices of living in patients with PCNSL. [ Time Frame: Analysis will be at 5 years. ]
  3. To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. [ Time Frame: Analysis at 3 years. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193973

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Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145
Illawarra Cancer Care Centre
Wollongong, New South Wales, Australia
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Mater QRI
South Brisbane, Queensland, Australia, 4101
Premion - Tugun
Tugun, Queensland, Australia, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Andrew Love Cancer Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
New Zealand
Auckland Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 4710
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Australasian Leukaemia and Lymphoma Group
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Study Chair: Peter O'Brien, FRANZCR Newcastle Mater Misericordiae Hospital

Additional Information:
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Responsible Party: Trans-Tasman Radiation Oncology Group (TROG) Identifier: NCT00193973     History of Changes
Other Study ID Numbers: TROG 01.02
ALLG LY4 ( Other Identifier: ALLG )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Primary CNS lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors