CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
filgrastim +6 morebiological
Likely dose
Methotrexate 8 g/sq m IV Days 1 & 15 (Cycles 1-3), Day 15 (Cycle 4), Day 1 (Cycle 5); Temozolomide 150 mg/sq m PO Days 7-11 (Cycles 1-5); Rituximab 375 mg/sq m IV Days 3, 10, 17, 24 (Cycle 1) and Days 3, 10 (Cycle 2); Cytarabine 2 g/sq m IV q12h x8 doses Days 1-4 (Cycle 6); Etoposide 5 mg/kg IV q12h x8 doses Days 1-4 (Cycle 6)AI-extracted
Key inclusion· 5
  • ✓Histologically confirmed newly diagnosed primary CNS lymphoma by brain biopsy/resection or positive CSF cytology
  • ✓No evidence of systemic non-Hodgkin's lymphoma on staging imaging and bone marrow biopsy
  • ✓Measurable contrast-enhancing disease on brain and spine MRI (unless CSF cytology positive)
  • ✓HIV negative
Key exclusion· 4
  • ✕Evidence of systemic non-Hodgkin's lymphoma
  • ✕Evidence of pleural effusions or ascites
  • ✕Concurrent palliative radiotherapy
  • ✕Pregnant or nursing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00098774
NCT00098774Phase 2Completed
CompareCT.gov

Intensive Chemotherapy And Immunotherapy In Patients With Newly Diagnosed Primary CNS Lymphoma

Alliance for Clinical Trials in Oncology·interventional·Posted Dec 9, 2004·Updated Jul 6, 2016

In Brief

A Phase 2 clinical trial evaluating filgrastim, rituximab, and 5 other interventions for Lymphoma. Completed, enrolled 47 participants across 30 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well rituximab given with combination chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2004
Enrollment StartOct 1, 2004
Primary CompletionJan 1, 2010
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 21.6 years ago

Interventions

filgrastimbiological

5 mcg/kg subQ injection daily Day 14 until ANC \> or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6)

rituximabbiological

375 mg/sq m IV infusion (max rate of 400 mg/hr) on Days 3, 10, 17, \& 24 of Cycle 1 nad Days 3 \& 10 of Cycle 2

cytarabinedrug

2 g/sq m IV infusion over 2 hours q 12 hrs x 8 doses Days 1-4 of Cycle 6

etoposidedrug

5 mg/kg IV infusion over 12 hrs q 12 hrs x 8 doses Days 1-4 of Cycle 6

leucovorin calciumdrug

100 mg/sq m IV infusion q 6 hrs starting 24 hrs after ea MTX dose until serum MTX \< or = 0.05uM Cycles 1-5.

methotrexatedrug

8 g/sq m IV infusion over 4 hrs Days 1 \& 15 Cycles 1, 2, \& 3; Day 15 Cycle 4 and Day 1 Cycle 5.

temozolomidedrug

150 mg/sq m PO Days 7-11 Cycles 1-5.