Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Berkeley, California.

Sponsor
Spectrum Pharmaceuticals, Inc
Study ID
NCT01549886
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Y-90-Zevalin — DRUG
    Day 8 - Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
  • Moxtezafin Gadolinium — DRUG
    Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily
  • Rituximab — DRUG
    Day 1 and Day 8: Rituximab 250 mg/m\^2 intravenous infusion

Study Details

The objectives of this study are to evaluate the efficacy and safety of the Zevalin regimen compared to Zevalin and motexafin gadolinium in patients with rituximab-refractory, low-grade or follicular Non-Hodgkin's Lymphoma (NHL). Effectiveness of the experimental regimen assessed by complete response rate within 6 months of study entry (primary endpoint), complete response rate within 3 months of study entry, and overall response rate within 6 month of study entry.

Key Dates

Start date
Nov 30, 2011
Status verified
Sep 2021
Primary completion
Jun 30, 2014
Completion
May 31, 2015

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MGD + Rituximab + Y-90-Zevalin
    Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie / kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
  • Active Comparator: Rituximab + Y-90-Zevalin
    Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push

Primary Outcome Measure

Complete Response Rate (CR) [ Time Frame: 6 Months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Alta Bates Summit Medical Center-HerrickBerkeleyCalifornia94704-
Providence Saint Joseph Medical CenterBurbankCalifornia91505-
Halifax Health- Center for OncologyDaytona BeachFlorida32114-
Rush University Medical CenterChicagoIllinois60612-
Loyola University ChicagoMaywoodIllinois60153-
Oncology SpecialistsPark RidgeIllinois60068-
University of Massachusetts - WorcesterWorcesterMassachusetts01655-
Hackensack Medical CenterHackensackNew Jersey07601-
West Virginia University, WVU HealthcareMorgantownWest Virginia26506-

Find similar trials in Berkeley, CA

By research site
Alta Bates Summit Medical Center-Herrick· Berkeley, CAProvidence Saint Joseph Medical Center· Burbank, CAHalifax Health- Center for Oncology· Daytona Beach, FLRush University Medical Center· Chicago, ILLoyola University Chicago· Maywood, ILOncology Specialists· Park Ridge, IL

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