Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• filgrastim — BIOLOGICAL
  5 mcg/kg subQ injection daily Day 14 until ANC \> or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6)
• rituximab — BIOLOGICAL
  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
• cytarabine — DRUG
  2 g/sq m IV infusion over 2 hours q 12 hrs x 8 doses Days 1-4 of Cycle 6
• etoposide — DRUG
  5 mg/kg IV infusion over 12 hrs q 12 hrs x 8 doses Days 1-4 of Cycle 6
• leucovorin calcium — DRUG
  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.
• methotrexate — DRUG
  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.
• temozolomide — DRUG
  150 mg/sq m PO Days 7-11 Cycles 1-5.

Study Details

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.

Key Dates

Start date

Oct 31, 2004

Status verified

Jul 2016

Primary completion

Jan 31, 2010

Completion

Sep 30, 2014

Study Design

Enrollment

47 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Intensive Combination Chemo & Immunotherapy
  Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)

Primary Outcome Measure

Complete Response Rate After Remission Induction [ Time Frame: 4 months ]

Locations (30)

Find similar trials in San Francisco, CA

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