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Phase II Intergroup Study of Combined Modality Therapy Using MTX/VCR/PCB/DM Followed by Radiotherapy plus ARA-C for Primary CNS Lymphoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Primary CNS Lymphoma

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedover 18NCIRTOG-9310
SWOG-9310, INT-0143

Objectives

I.  Assess the rate of tumor response to 
methotrexate/vincristine/procarbazine/dexamethasone administered prior to 
radiotherapy in patients with primary central nervous system lymphoma.

II.  Compare survival of these patients to historical controls treated with 
radiotherapy alone.

III.  Assess the long-term toxicity of this regimen.

IV.  Provide data for consideration of a randomized trial to compare 
chemotherapy alone vs. chemotherapy plus radiotherapy in an effort to reduce 
the morbidity of cranial irradiation.

Entry Criteria

Disease Characteristics:


Histologically proven non-Hodgkin's lymphoma of the brain
  Registration within 4 weeks of histologic diagnosis required

Patients with inconclusive biopsy or who are not candidates for brain biopsy
eligible provided:
  Cranial CT or MRI indicates no leptomeningeal nonparenchymal lymphoma
  Non-Hodgkin's lymphoma is documented by CSF cytology or by vitreous or uveal
     biopsy

Concurrent registration on protocol RTOG 9308 (tissue repository study)
allowed


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior cranial irradiation

Surgery:
  Not specified


Patient Characteristics:


Age:
  Over 18

Performance status:
  Karnofsky 50%-100%

Life expectancy:
  At least 8 weeks

Hematopoietic:
  ANC at least 2,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no more than 2.0 mg/dL
  AST no more than 2 times normal

Renal:
  Creatinine clearance at least 50 mL/min/1.73 sqm
  Serum electrolytes normal

Other:
  HIV negative
  No pre-existing immunodeficiency (e.g., prior renal transplant)
  No second malignancy within 5 years except:
     Basal cell carcinoma of the skin
     In situ cervical carcinoma
  No pregnant or nursing women


Expected Enrollment

A total of 28 patients will be entered over approximately 10 months.  As of 
08/96, 40 additional patients will be entered over approximately 20 months.

Outline

Patients are sequentially treated on Regimens A, B, and C.  The following 
acronyms are used:
  ARA-C   Cytarabine, NSC-63878
  CF      Leucovorin calcium, NSC-3590
  DM      Dexamethasone, NSC-345211
  MTX     Methotrexate, NSC-740
  PCB     Procarbazine, NSC-77213
  VCR     Vincristine, NSC-67574
  WBI     Whole-Brain Irradiation

Regimen A:  4-Drug Combination Chemotherapy plus CNS Therapy.  DM; MTX/CF; 
VCR; PCB; plus IT MTX.

Regimen B:  Cranial Irradiation.  WBI using Co60 or megavoltage equipment up 
to 10 MV photons.

Regimen C:  Single-Agent Chemotherapy.  ARA-C.

Published Results

Fisher B, Seiferheld W, Schultz C, et al.: Secondary analysis of Radiation Therapy Oncology Group study (RTOG) 9310: an intergroup phase II combined modality treatment of primary central nervous system lymphoma. J Neurooncol 74 (2): 201-5, 2005.[PUBMED Abstract]

DeAngelis LM, Seiferheld W, Schold SC, et al.: Combination chemotherapy and radiotherapy for primary central nervous system lymphoma: Radiation Therapy Oncology Group Study 93-10. J Clin Oncol 20 (24): 4643-8, 2002.[PUBMED Abstract]

Fisher BJ, Seiferheld W, Schultz C, et al.: Secondary analysis of RTOG 9310: an intergroup phase II combined modality treatment of primary central nervous system lymphoma with chemotherapy and hyperfractionated radiotherapy. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-302, 166, 2001.

DeAngelis L, Seiferheld W, Schold S, et al.: Combined modality treatment of primary central nervous system lymphoma (PCNSL): RTOG 93-10.. [Abstract] Proceedings of the American Society of Clinical Oncology 18: 537A, 140a, 1999.

Related Publications

Schultz C, Scott C, DeAngelis L, et al.: Radiation therapy (RT) alone vs. pre-RT chemotherapy (CTX) for the treatment of primary CNS lymphoma (PCNSL): age matched survival analysis of RTOG 83-15 and RTOG 93-10. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A617, 2000.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Lisa DeAngelis, MD, Protocol chair
Ph: 212-639-7997; 800-525-2225

Southwest Oncology Group

Alan Lichtin, MD, Protocol chair
Ph: 216-444-6823; 800-862-7798

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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