Non Hodgkin Lymphoma Clinical Trial
Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin’s Lymphoma
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
Primary
Determine the response rate in patients with recurrent primary CNS non-Hodgkin's lymphoma treated with rituximab, temozolomide, and methylprednisolone.
Secondary
Determine the overall and 6-month progression-free survival of patients treated with this regimen.
OUTLINE: Induction therapy: Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 and oral temozolomide daily on days 1-7 and 15-21. After day 28, patients with stable disease or better proceed to consolidation therapy.
Consolidation therapy: Patients receive oral temozolomide daily on days 1-5. Treatment repeats every 28 days for up to 6 courses. Patients achieving a complete remission proceed to maintenance therapy.
Maintenance therapy: Patients receive methylprednisolone IV over 2 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 13.3 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy
Recurrent disease
Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan
Radiographical evidence of tumor progression by MRI or CT scan
Steroid therapy must be stable for 5 days prior to scan
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 60-100%
Life expectancy
More than 8 weeks
Hematopoietic
WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL (transfusion allowed)
Hepatic
SGOT < 2 times upper limit of normal (ULN)
Bilirubin < 2 times ULN
No active or latent hepatitis B infection
Renal
Creatinine < 1.5 mg/dL OR
Creatinine clearance ≥ 60 mL/min
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No uncontrolled significant medical illness that would preclude study treatment
No active infection
No active HIV infection
No concurrent disease that would dangerously alter drug metabolism or obscure toxicity
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 7 days since prior interferon or thalidomide
No concurrent prophylactic filgrastim (G-CSF)
No concurrent immunotherapy
Chemotherapy
No prior temozolomide
At least 14 days since prior methotrexate
At least 21 days since prior procarbazine
At least 42 days since prior nitrosoureas
No other concurrent chemotherapy
Endocrine therapy
See Disease Characteristics
At least 7 days since prior tamoxifen
No concurrent hormonal therapy
Radiotherapy
No concurrent radiotherapy
Surgery
Not specified
Other
Recovered from all prior therapy
At least 28 days since prior investigational agents
At least 28 days since other prior cytotoxic therapy
At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed)
No other concurrent investigational drugs
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There are 7 Locations for this study
San Francisco California, 94115, United States
Boston Massachusetts, 02115, United States
Durham North Carolina, 27710, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
San Antonio Texas, 78284, United States
Madison Wisconsin, 53792, United States
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