NCT00334438

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, 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 without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Jul 2006

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2006

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 23, 2016

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

June 6, 2006

Last Update Submit

December 22, 2016

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of bortezomib

    2 years

  • Dose-limiting toxicity

    8 weeks

Secondary Outcomes (1)

  • Response rate

    5 years

Study Arms (1)

Zevalin + Velcade Single Arm Study

OTHER

Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)

Biological: rituximabDrug: bortezomibRadiation: yttrium Y 90 ibritumomab tiuxetanRadiation: Indium 111 ibritumomab tiuxetan

Interventions

rituximabBIOLOGICAL

250mg/m2, IV, Days 1 and 8

Also known as: Rituxan
Zevalin + Velcade Single Arm Study
bortezomibDRUG

dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15

Also known as: Velcade
Zevalin + Velcade Single Arm Study
yttrium Y 90 ibritumomab tiuxetanRADIATION

Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8

Zevalin + Velcade Single Arm Study
Indium 111 ibritumomab tiuxetanRADIATION

5cmCi; IV day 1

Zevalin + Velcade Single Arm Study

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma * Bone marrow biopsy required for pretreatment evaluation * Unilateral bone marrow biopsy allowed * Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping * Relapsed or refractory disease as defined by disease progression after initial complete response (CR) or failure to achieve CR * No bone marrow involvement ≥ 25% within the past 30 days * No pleural effusion or significant ascites * No active CNS involvement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * AST ≤ 2.5 times upper limit of normal (ULN) * Total bilirubin ≤ 2.5 times ULN * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Hepatitis B surface antigen negative * No current infection with hepatitis B virus * No HIV positivity * No neuropathy or neuropathic pain ≥ grade 2 * No history of allergic reaction to boron or mannitol * No active serious infection or medical or psychiatric illness that would preclude study therapy * No other malignancy within the past 5 years except for the following: * Basal cell or squamous cell carcinoma of the skin that has been completely resected * In situ malignancy that has been completely resected * T1-T2a, N0, M0 prostate cancer treated with a prostatectomy or radiotherapy within the past 2 years with an undetectable PSA level * No other condition, including any of the following: * Myocardial infarction within the past 6 months * New York Heart Association class III-IV heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Electrocardiographic evidence of acute ischemia or active conduction system abnormalities PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, or surgical resection of malignancy * No limitations on the number of prior therapies * More than 4 weeks since prior major surgery * More than 14 days since prior filgrastim (G-CSF) or sargramostim (GM-CSF) * More than 14 days since prior and no other concurrent investigational agents * Concurrent participation in a nontreatment study allowed * No prior radioimmunotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

RituximabBortezomibibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas C. Shea, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 7, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2011

Last Updated

December 23, 2016

Record last verified: 2016-12

Locations

US(2)