Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma - Full Text View

Sponsors and Collaborators:	Trans-Tasman Radiation Oncology Group (TROG) Australasian Leukaemia and Lymphoma Group (ALLG)
Information provided by:	Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:	NCT00193973

Purpose

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	Intervention	Phase
Primary Central Nervous System Lymphoma	Drug: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C Procedure: Radiotherapy	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Filgrastim Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma

Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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. ]

Enrollment:	20
Study Start Date:	July 2001
Estimated Study Completion Date:	July 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193973

Locations

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

Sponsors and Collaborators

Trans-Tasman Radiation Oncology Group (TROG)

Australasian Leukaemia and Lymphoma Group (ALLG)

Investigators

Study Chair:

Peter O'Brien, FRANZCR

Newcastle Mater Misericordiae Hospital

More Information

Click here for more information about this study on the TROG official website This link exits the ClinicalTrials.gov site

Study ID Numbers:	TROG 01.02, ALLG LY4
Study First Received:	September 13, 2005
Last Updated:	May 4, 2007
ClinicalTrials.gov Identifier:	NCT00193973
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):

Lymphoma
PCNSL
Primary CNS lymphoma

Study placed in the following topic categories:

Folic Acid
Lymphatic Diseases
Idarubicin
Immunoproliferative Disorders
Methotrexate

Lymphoproliferative Disorders
Lymphoma
Cytarabine
Central nervous system lymphoma, primary

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists

Antibiotics, Antineoplastic
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009