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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	over 18	NCI	RTOG-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.

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.

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