Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Australasian Leukaemia and Lymphoma Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00193973
First received: September 13, 2005
Last updated: August 8, 2013
Last verified: August 2013
  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
Radiation: Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma

Resource links provided by NLM:


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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: Yes ]
  • Assess functional indices of living in patients with PCNSL. [ Time Frame: Analysis will be at 5 years. ] [ Designated as safety issue: No ]
  • To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01. [ Time Frame: Analysis at 3 years. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: July 2001
Study Completion Date: August 2013
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Investigators
Study Chair: Peter O'Brien, FRANZCR Newcastle Mater Misericordiae Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00193973     History of Changes
Other Study ID Numbers: TROG 01.02, ALLG LY4
Study First Received: September 13, 2005
Last Updated: August 8, 2013
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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Idarubicin
Methotrexate
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 20, 2014