Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
Condition: Brain and Central Nervous System Tumors; Drug/Agent Toxicity by Tissue/Organ; Lymphoma; Thrombocytopenia
MeSH terms: Lymphoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Thrombocytopenia; Drug-Related Side Effects and Adverse Reactions
Intervention: Rituxan; Cyclophosphamide; Etoposide; Etoposide phosphate; Carboplatin; Sodium thiosulfate; Neupogen; Neulasta; Cytarabine
Intervention description: Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year.; Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year; Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead.; Dose 200mg/m2 infused IV x 2 days; Every 4 weeks for up to one year. Etoposide may be given instead.; Dose: 200mg/m2 x 2 days infused IA with BBBD; Every 4 weeks for up to one year.; Dose: 4 hrs post carboplatin = 20gm/m2;
Dose: 8 hrs post carboplatin = 16gm/m2
Infused IV x 2 days; 48 hours after chemotherapy, QD x 7-10 days until WBC greater than 5000. Neulasta (Pegfilgrastim) may be given instead.; Dose: 6mg, 24-72 hours after chemotherapy. Neupogen may be given instead.; Dose: 40mg on Day 14 following chemotherapy
Intervention MeSH terms: Cytarabine; Sodium thiosulfate; Cyclophosphamide; Rituximab; Carboplatin; Etoposide; Etoposide phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Months
Maximum age: 75 Years
Healthy volunteers: No
Keywords: drug/agent toxicity by tissue/organ; thrombocytopenia; intraocular lymphoma; primary central nervous system non-Hodgkin lymphoma; primary central nervous system Hodgkin lymphoma

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.
    

Eligibility 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