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AzTrials

LymphomaPhase 1NCT00334438

Bortezomib, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory Low-Grade, Follicular, or Mantle Cell Non-Hodgkin's Lymphoma

A Phase 1 study testing rituximab, bortezomib and yttrium Y 90 ibritumomab tiuxetan in people with Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
rituximab, bortezomib and yttrium Y 90 ibritumomab tiuxetan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
Jul 2006to Oct 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Chapel Hill, North Carolina, 27599-7295

  • Hackensack University Medical Center Cancer Center

    Hackensack, New Jersey, 07601

Other trials in United States

About this study

Official title: A Phase I Study Evaluating Combined Zevalin (Ibritumomab Tiuxetan) and Valcade (Bortezomib) in Relapsed/Refractory Low-Grade or Follicular B-Cell and Mantle Cell Lymphoma

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose (MTD) of bortezomib in combination with rituximab and yttrium Y 90 ibritumomab tiuxetan in patients with relapsed or refractory low-grade, follicular B-cell, or mantle cell non-Hodgkin's lymphoma.
  • Determine the dose-limiting toxicity of this regimen in these patients.

Secondary

  • Determine the response rate in patients treated with this regimen.

OUTLINE: This is a multicenter, open-label, nonrandomized, dose-escalation study of bortezomib.

Patients receive rituximab IV over 4 hours followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 to assess biodistribution. Patients without altered biodistribution receive rituximab IV over 4 hours followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Patients also receive bortezomib IV over 3-5 seconds on days 4, 8, 11, and 15.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients may be treated at the MTD.

After completion of study treatment, patients are followed every 3 months for 18 months and then every 6 months thereafter.

Conditions
Lymphoma
Being tested
rituximab, bortezomib, yttrium Y 90 ibritumomab tiuxetan, Indium 111 ibritumomab tiuxetan
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent small lymphocytic lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabBiological

    Also called Rituxan

    250mg/m2, IV, Days 1 and 8

  • bortezomibDrug

    Also called Velcade

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

  • yttrium Y 90 ibritumomab tiuxetanRadiation

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

  • Indium 111 ibritumomab tiuxetanRadiation

    5cmCi; IV day 1

Study groups in NCT00334438
Study groupRoleWhat they receive
Zevalin + Velcade Single Arm StudyOtherZevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)
Receives: Biological: rituximab; Drug: bortezomib; Radiation: yttrium Y 90 ibritumomab tiuxetan; Radiation: Indium 111 ibritumomab tiuxetan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of bortezomib

    Measured: 2 years

  2. Dose-limiting toxicity

    Measured: 8 weeks

Secondary outcomes (1)

  1. Response rate

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2008
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334438
Sponsor's protocol ID
LCCC 0525
Other IDs
CDR0000550130
Status last verified
Dec 2016
First submitted
6 Jun 2006
Last updated
23 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rituximab, bortezomib and yttrium Y 90 ibritumomab tiuxetan in people with Lymphoma, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of bortezomib (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.

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