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

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.

Conditions

• Brain and Central Nervous System Tumors
• Drug/Agent Toxicity by Tissue/Organ
• Lymphoma
• Thrombocytopenia

Interventions

DRUG

Rituxan

Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year.

DRUG

Cyclophosphamide

Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year

DRUG

Etoposide

Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead.

DRUG

Etoposide phosphate

Dose 200mg/m2 infused IV x 2 days; Every 4 weeks for up to one year. Etoposide may be given instead.

DRUG

Carboplatin

Dose: 200mg/m2 x 2 days infused IA with BBBD; Every 4 weeks for up to one year.

DRUG

Sodium thiosulfate

Dose: 4 hrs post carboplatin = 20gm/m2; Dose: 8 hrs post carboplatin = 16gm/m2 Infused IV x 2 days

DRUG

Neupogen

48 hours after chemotherapy, QD x 7-10 days until WBC greater than 5000. Neulasta (Pegfilgrastim) may be given instead.

DRUG

Neulasta

Dose: 6mg, 24-72 hours after chemotherapy. Neupogen may be given instead.

DRUG

Cytarabine

Dose: 40mg on Day 14 following chemotherapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Edward A. Neuwelt, MD · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Months

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-01-31

Primary Completion

2010-06-30

Completion

2010-12-31

Countries

• United States

Study Locations