Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00248534
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00248534
Study Brief:
Protocol Section:
NCT00248534