Status:
TERMINATED
Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 o...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00248534
Start Date
September 1 2005
End Date
September 1 2012
Last Update
September 4 2018
Active Locations (7)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
4
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232