Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Trans-Tasman Radiation Oncology Group (TROG).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Collaborator:
Australasian Leukaemia and Lymphoma Group
Information provided by:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00193973
First received: September 13, 2005
Last updated: May 6, 2009
Last verified: May 2009
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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: | Allocation: Non-Randomized 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:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Methotrexate
Methotrexate sodium
Idarubicin hydrochloride
Idarubicin
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | July 2009 |
| 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
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: | May 6, 2009 |
| 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 May 23, 2013