Back to resultsCombination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cytarabine
methotrexate
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring primary central nervous system non-Hodgkin lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord No Burkitt's lymphoma or low grade T-cell lymphoma Must have at least 1 measurable lesion No AIDS-related primary central nervous system lymphoma (PCNSL) No disease confined to the eye without other localization in the CNS PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: Karnofsky 40-100% Neurological functional status 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No serious impairment of hepatic function Renal: No serious impairment of renal function Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min Cardiovascular: No serious impairment of cardiac function Other: HIV negative No congenital or acquired immunodeficiency syndrome No prior/concurrent systemic lymphoma No prior malignancy except: Adequately treated non-melanoma skin cancer Carcinoma in situ of the cervix uteri Not pregnant No severe uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent treatment with immunosuppressive drug Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroid use for less than 3 weeks allowed Radiotherapy: Not specified Surgery: No prior organ transplantation
Sites / Locations
- U.Z. Gasthuisberg
- Institut Gustave Roussy
- Atrium Medical Centre
- Academisch Ziekenhuis Maastricht
- Rotterdam Cancer Institute
- Dr. Bernard Verbeeten Instituut
- Academisch Ziekenhuis Utrecht
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00003061
First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00003061
Brief Title
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
Official Title
Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.
Detailed Description
OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy regimen.
OUTLINE: Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and 15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no later than 3 weeks after completing chemotherapy. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
primary central nervous system non-Hodgkin lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord No Burkitt's lymphoma or low grade T-cell lymphoma Must have at least 1 measurable lesion No AIDS-related primary central nervous system lymphoma (PCNSL) No disease confined to the eye without other localization in the CNS
PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: Karnofsky 40-100% Neurological functional status 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No serious impairment of hepatic function Renal: No serious impairment of renal function Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min Cardiovascular: No serious impairment of cardiac function Other: HIV negative No congenital or acquired immunodeficiency syndrome No prior/concurrent systemic lymphoma No prior malignancy except: Adequately treated non-melanoma skin cancer Carcinoma in situ of the cervix uteri Not pregnant No severe uncontrolled infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent treatment with immunosuppressive drug Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroid use for less than 3 weeks allowed Radiotherapy: Not specified Surgery: No prior organ transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Poortmans, MD, PhD
Organizational Affiliation
Dr. Bernard Verbeeten Instituut
Official's Role
Study Chair
Facility Information:
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Atrium Medical Centre
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
14981168
Citation
Harder H, Holtel H, Bromberg JE, Poortmans P, Haaxma-Reiche H, Kluin-Nelemans HC, Menten J, van den Bent MJ. Cognitive status and quality of life after treatment for primary CNS lymphoma. Neurology. 2004 Feb 24;62(4):544-7. doi: 10.1212/wnl.62.4.544.
Results Reference
result
PubMed Identifier
14597741
Citation
Poortmans PM, Kluin-Nelemans HC, Haaxma-Reiche H, Van't Veer M, Hansen M, Soubeyran P, Taphoorn M, Thomas J, Van den Bent M, Fickers M, Van Imhoff G, Rozewicz C, Teodorovic I, van Glabbeke M; European Organization for Research and Treatment of Cancer Lymphoma Group. High-dose methotrexate-based chemotherapy followed by consolidating radiotherapy in non-AIDS-related primary central nervous system lymphoma: European Organization for Research and Treatment of Cancer Lymphoma Group Phase II Trial 20962. J Clin Oncol. 2003 Dec 15;21(24):4483-8. doi: 10.1200/JCO.2003.03.108. Epub 2003 Nov 3.
Results Reference
result
Citation
Kluin-Nelemans JC, Poortmans P, Haaxma-Reicher H, et al.: Final results of the EORTC phase II trial 20962 evaluating high-dose MTX-based chemotherapy followed by consolidating radiotherapy in non-Aids related primary central nervous system lymphoma. [Abstract] Blood 100 (11 pt 1): A-3071, 776a, 2002.
Results Reference
result
Learn more about this trial
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
We'll reach out to this number within 24 hrs