Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m^2 (cumulative total dose of 1250 mg/m^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
Eligibility criteria:
Inclusion Criteria:

Patients ≥ 18 years of age and ≤ 75 years of age
Patients must have Central Nervous System (CNS) involvement with a mature B-cell non-Hodgkin's Lymphoma, (WHO criteria)

Patients must meet one of the below criteria:

Patients who have achieved a complete response (CR) or partial response (PR) after initial therapy for Central Nervous System (CNS) B-cell lymphoma, OR
Patients with relapsed or progressed disease following therapy for CNS B-cell lymphoma who has achieved a subsequent CR or PR following salvage chemotherapy, OR
Patients who are initially refractory to therapy for CNS B-cell lymphoma but who have achieved a CR or PR following a salvage chemotherapy regimen, OR
Patients who have developed CNS relapse from systemic B-cell Non-Hodgkin's lymphoma, and have evidence of chemotherapy sensitive lymphoma.
Patients fit for autologous stem cell transplantation
Patients able to understand and willing to sign a written informed consent document

Exclusion Criteria:

Patients whose life expectancy is severely limited by diseases other than malignancy
Karnofsky Performance Score <60
Patients who are pregnant or breastfeeding
Patients who are HIV seropositive
Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Patients with symptomatic coronary artery disease, uncontrolled congestive heart failure. Left Ventricular Ejection Fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is <30%
Patients requiring supplementary continuous oxygen. DLCO is not required to be measured, however if it is measured, patient is excluded if DLCO <35%.

Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension. Patients with any of the following liver function abnormalities will be excluded

Fulminant liver failure
Cirrhosis with evidence of portal hypertension or bridging fibrosis
Alcoholic hepatitis
Esophageal varices
A history of bleeding esophageal varices
Hepatic encephalopathy
Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
Ascites related to portal hypertension
Chronic viral hepatitis with total serum bilirubin >3 mg/dL
Symptomatic biliary disease
Patients with non-B-cell lymphomas or brain tumors that are not lymphomas are Excluded from the study. Non-B-cell lymphomas include: any T-cell lymphoma, natural killer (NK)-cell lymphomas, and Hodgkin lymphomas
Patients for whom an insufficient number of stem cells (<2 X 106/kg) have been collected