Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Rituximab; Sodium thiosulfate

Criteria

INCLUSION CRITERIA:

• Signed informed consent form in accordance with institutional guidelines

• Histologically or cytologically confirmed primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis

• CD20 positive disease

• Progressive or relapsed disease during or after completion of prior methotrexate-based chemotherapy

• Aged 18 months to 75 years

• Performance status ECOG 0-3 OR Karnofsky 30-100%

• Hematocrit at least 25% (transfusion or epoetin alfa allowed)

• Absolute granulocyte count at least 1,200/mm^3

• Platelet count at least 100,000/mm^3 OR at least lower limit of normal

• Bilirubin no greater than 2.0 times upper limit of normal

• Creatinine less than 1.8 mg/dL

• Calculated Creatinine clearance (CrCl) at least 50 mL/min

• Adequate cardiac function to tolerate general anesthesia

• Adequate pulmonary function to tolerate general anesthesia

• Available for follow-up for 1 year post therapy

• Fertile patients must use effective contraception for a minimum of 2 months before and during study participation

EXCLUSION CRITERIA:

• Radiographic signs of intra-cranial herniation and/or spinal block

• HIV positive

• Systemic lymphoma

• Positive serum HCG, pregnant or lactating

• Allergy to study agents

• Hepatitis B or hepatitis C positive