Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
- Conditions
- Drug/Agent Toxicity by Tissue/OrganBrain and Central Nervous System TumorsLymphomaThrombocytopenia
- Interventions
- Registration Number
- NCT00074165
- Lead Sponsor
- OHSU Knight Cancer Institute
- Brief 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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate, in terms of complete response rate, in patients with refractory or recurrent primary CNS lymphoma.
Secondary
* Determine the overall survival and 2-year progression-free survival of patients treated with this regimen.
* Determine the quality of life and cognitive function of patients treated with this regimen.
* Determine the neurotoxicity of this regimen in these patients.
* Determine the percentage of patients with ototoxicity over time after treatment with this regimen.
* Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1. On days 2 and 3, patients receive carboplatin intra-arterially over 10 minutes, cyclophosphamide IV over 10 minutes, and etoposide or etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption. Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8 hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on day 14. Beginning 48 hours after the last dose of chemotherapy, patients receive filgrastim (G-CSF)\* subcutaneously (SC) daily for 7-10 days or until blood counts recover. Treatment repeats every 4 weeks for up to 12 courses.
NOTE: \* Alternatively, patients may receive a single dose of pegfilgrastim SC, administered 48 hours after the completion of chemotherapy
Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam; once weekly for 1 month; and then monthly for 1 year.
Quality of life is assessed at baseline, every 3 months during treatment, within 30 days of final treatment, then every 6 months for 1 year, and then annually thereafter.
Patients are followed monthly for 3 months, every 2 months for 8 months, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 11-25 patients will be accrued for this study within 7-10 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects Neupogen - All subjects Cyclophosphamide - All subjects Neulasta - All subjects Etoposide phosphate - All subjects Rituxan - All subjects Etoposide - All subjects Cytarabine - All subjects Sodium thiosulfate - All subjects Carboplatin -
- Primary Outcome Measures
Name Time Method Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years. 2 years Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.
- Secondary Outcome Measures
Name Time Method Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response 5 years Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.
Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression 5 years Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months 5 years Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment 2 years Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment 2 years
Trial Locations
- Locations (2)
Good Samaritan Hospital Cancer Treatment Center, Hatton Institute
🇺🇸Cincinnati, Ohio, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States