Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
N/A
N/A
Both
Brain and Central Nervous System Tumors, Lymphoma
Trial Information
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
OBJECTIVES:
Primary
- Determine the rate of toxicity, in terms of percentage of patients with grade 4
neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction
therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and
temozolomide followed by consolidation therapy comprising cytarabine and etoposide
phosphate.
Secondary
- Determine the efficacy of this regimen, in terms of the 4-month and 12-month complete
and best response rate, in these patients.
- Determine the progression-free and overall survival of patients treated with this
regimen.
- Determine the percentage of patients experiencing toxicity or neurotoxicity due to this
regimen.
- Determine the treatment-related mortality rate in patients treated with this regimen.
- Document the neurocognitive changes in these patients using the Mini-Mental Status
Examination during the first year of treatment with this regimen.
OUTLINE: This is a pilot, multicenter study.
- Induction therapy: Patients receive high-dose methotrexate IV over 4 hours on days
1,15, 29, 43, 57, 71, and 99; leucovorin calcium IV every 6 hours on days 2-4, 16-18,
30-32, 44-46, 58-60, 72-74, and 100-102; oral temozolomide on days 7-11, 35-39, 63-67,
91-95, and 119-123; and rituximab IV on days 3, 17, 31, 45, 59, and 74. Treatment
continues in the absence of disease progression or unacceptable toxicity. Patients who
achieve complete response proceed to consolidation therapy.
- Consolidation therapy I: Beginning 3-4 weeks after completing induction therapy,
patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin calcium IV
every 6 hours on days 2-4, and oral temozolomide on days 7-11.
- Consolidation therapy II: Beginning 3-5 weeks after completing consolidation therapy I,
patients receive cytarabine IV over 2 hours twice daily and etoposide phosphate IV
continuously on days 1-4 and filgrastim (G-CSF) subcutaneously beginning on day 14 and
continuing until blood counts recover.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued to this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed untreated primary CNS lymphoma (PCNSL) confirmed by 1 of the
following methods:
- Brain biopsy or resection
- Patients diagnosed with T-cell PCNSL allowed but will not receive rituximab
on study
- Cerebrospinal fluid (CSF) cytology
- Positive CSF cytology with or without measurable intracranial disease
- Vitreal biopsy
- Histologic confirmation of vitreal lymphoma with measurable intracranial
tumor
- No evidence of systemic non-Hodgkin's lymphoma
- CT scan of chest, abdomen, and pelvis or bone marrow biopsy negative for
extracerebral source of lymphoma
- No evidence of pleural effusions or ascites
- MRI of brain and spine (plus gadolinium) must have measurable contrast enhancing
disease unless CSF cytology is positive
PATIENT CHARACTERISTICS:
- Karnofsky performance score 50-100%
- HIV negative
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No concurrent salicylates, nonsteroidal anti-inflammatory drugs, sulfonamides, or
penicillins within the past week
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
rate of toxicity in patients with untreated primary CNS lymphoma
Outcome Description:
Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Outcome Time Frame:
up to 8 months
Safety Issue:
Yes
Principal Investigator
James L. Rubenstein, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000458052
NCT ID:
NCT00416819
Start Date:
September 2003
Completion Date:
December 2014
Related Keywords:
- Brain and Central Nervous System Tumors
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- primary central nervous system Hodgkin lymphoma
- Lymphoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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