Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00248534
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    given IV days 1,8, 15 and 22
  • methylprednisolone — DRUG
    2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)
  • temozolomide — DRUG
    Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

Study Details

RATIONALE: 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. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.

Key Dates

Start date
Sep 30, 2005
Status verified
Aug 2018
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IV Rituximab
    IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

Primary Outcome Measure

Percentage of Participants With Objective Response [ Time Frame: 2 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBostonMassachusetts02115-
Duke Comprehensive Cancer CenterDurhamNorth Carolina27710-
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-
M. D. Anderson Cancer Center at University of TexasHoustonTexas77030-4009-
University of Texas Health Science Center at San AntonioSan AntonioTexas78284-6220-
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadisonWisconsin53792-6164-

Find similar trials in San Francisco, CA

By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CADana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute· Boston, MADuke Comprehensive Cancer Center· Durham, NCHillman Cancer Center at University of Pittsburgh Cancer Institute· Pittsburgh, PAM. D. Anderson Cancer Center at University of Texas· Houston, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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