Study of Bortezomib in Combination With Cyclophosphamide and Rituximab

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00958256
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Bortezomib 1.3 mg/m\^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.
  • Rituximab — DRUG
    375 mg/m\^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.
  • Cyclophosphamide — DRUG
    300 mg/m\^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle
  • Mesna — DRUG
    600 mg/m\^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.
  • G-CSF — DRUG
    5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.

Study Details

The goal of this clinical research study is to learn if bortezomib when given in combination with cyclophosphamide and rituximab can help to control mantle cell lymphoma. The safety of this drug combination will also continue to be studied.

Key Dates

Start date
Aug 31, 2009
Status verified
Mar 2015
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

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

Arms

  • Experimental: Bortezomib with Cyclophosphamide and Rituximab
    Bortezomib 1.3 mg/m\^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m\^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m\^2 IV on Day 1. Mesna 600 mg/m\^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.

Primary Outcome Measure

Response Rate [ Time Frame: Evaluation of disease after 2 cycles (approximately 6 weeks). ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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