AzTrials
AzTrials

LymphomaPhase 2NCT00851552

Bortezomib, Doxorubicin Hydrochloride Liposome, and Rituximab in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment

A Phase 2 study testing rituximab, bortezomib and pegylated liposomal doxorubicin hydrochloride in people with Lymphoma, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab, bortezomib and pegylated liposomal doxorubicin hydrochloride
Type of treatment
Injection or infusion
How many people
9 participants
Where
1 siteUnited States
Study dates
Jan 2009to Sep 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of CD20-positive diffuse large B-cell lymphoma, including any of the following morphological variants:
  • Centroblastic
  • Immunoblastic
  • T-cell/histiocyte-rich
  • Anaplastic
  • Mediastinal (thymic) large B-cell lymphoma
  • Intravascular large B-cell lymphoma
  • Relapsed or refractory disease
  • Measurable disease, defined as tumor size 2 cm²
  • Must have received ≥ 1 prior standard chemotherapy regimen
  • No Burkitt or precursor B-lymphoblastic lymphoma
  • No brain involvement or evidence of CNS lymphoma

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 70-100% OR ECOG PS 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/μL*
  • Platelet count ≥ 100,000/μL*
  • Creatinine < 2.5 mg/dL OR > 40 mL/min*
  • Hemoglobin > 8.0 g/dL*
  • AST/ALT < 2 times upper limit of normal (ULN) (< 3 times ULN with liver involvement)*
  • Alkaline phosphatase < 2 times ULN (< 3 times ULN with liver involvement)*
  • Total bilirubin < 2 times ULN (< 3 times ULN with liver involvement or Gilbert disease)* NOTE: *Unless attributable to non-Hodgkin lymphoma
  • LVEF ≥ 50% by MUGA scan or ECHO
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of therapy
  • No HIV positivity
  • No hepatitis B positivity
  • Peripheral neuropathy < grade 2 as defined by NCI CTCAE v 3.0
  • No history of uncontrolled orthostatic hypotension
  • None of the following cardiac conditions:
  • Myocardial infarction within the past 6 months
  • New York Heart Association class II-IV congestive heart failure
  • Uncontrolled angina
  • Severe uncontrolled ventricular arrhythmias
  • Clinically significant pericardial disease
  • ECG evidence of acute ischemic or active conduction system abnormalities
  • No hypersensitivity to bortezomib, boron, or mannitol
  • No history of allergic reactions to compounds containing boron, mannitol, bortezomib, conventional formulation of doxorubicin hydrochloride, or the components of pegylated liposomal doxorubicin hydrochloride
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Poorly controlled hypertension
  • Diabetes mellitus
  • Serious medical or psychiatric conditions that would interfere with adherence to or completion of this study
  • No other primary malignancy except squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, superficial bladder carcinoma, or previously treated localized prostate cancer with normal PSA levels and disease-free for ≥ 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from significant toxicity associated with prior surgery, radiotherapy, chemotherapy, or immunotherapy
  • Prior rituximab or other monoclonal immunotherapy allowed
  • More than 4 weeks since prior investigational drugs
  • More than 4 weeks since prior chemotherapy
  • More than 4 weeks since prior major surgery, other than diagnostic surgery
  • No prior doxorubicin hydrochloride (or equivalent) anthracycline treatment exceeding 400 mg/m²
  • No concurrent corticosteroids, except to control a transient inflammatory reaction (i.e., skin rash or hives)
  • Concurrent non-steroidal hormones administered for non-lymphoma related conditions (e.g., insulin for diabetes) allowed
  • No concurrent radiotherapy
  • No other concurrent antitumor or chemotherapeutic agents
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

Other trials in United States

About this study

Official title: A Phase II Study of VDR (VELCADE™, DOXIL® and RITUXAN™) in Relapsed/Refractory Diffuse Large B-cell Lymphoma

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell 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 cell-killing substances to them. Giving bortezomib together with doxorubicin hydrochloride liposome and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and rituximab works in treating patients with diffuse large B-Cell lymphoma that has relapsed or not responded to treatment.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the overall objective response rate (i.e., complete and partial response) in patients with relapsed or refractory, CD20-positive, diffuse large B-cell lymphoma treated with bortezomib, pegylated liposomal doxorubicin hydrochloride, and rituximab.

Secondary

  • To assess the toxicity/safety profile associated with this regimen.
  • To conduct correlative translational research studies.

OUTLINE: Patients receive bortezomib IV on days 1, 4, 8, and 11, pegylated liposomal doxorubicin hydrochloride IV on day 11, and rituximab IV on day 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Tissue and blood samples are collected periodically for correlative studies. Samples are analyzed for expression of CD11b/CD18, CD32, CD 33, CD62, CD64, CD69, and CD56 by flow cytometric analysis of neutrophils, NK cells, and monocytes; antibody-dependent cellular and complement-mediated cytotoxicity; and genotypic analysis of polymorphisms by PCR. Autologous neoplastic B-cells derived from tissue samples are used for genetic and protein profiling.

After completion of study therapy, patients are followed periodically for 4 years.

Conditions
Lymphoma
Being tested
rituximab, bortezomib, pegylated liposomal doxorubicin hydrochloride, gene expression analysis, polymerase chain reaction
Keywords
recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Large-Cell, Anaplastic

What participants receive

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

What is being measured

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

  1. Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21

    Measured: at weeks 9 and 21

Secondary outcomes (1)
  1. Safety

    Measured: 2 years

Timeline

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

  1. First posted26 Feb 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2011
  4. Study completionSep 2011

Why it stopped: Lack of sponsor support

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00851552
Sponsor's protocol ID
CDR0000635486
Other IDs
RPCI-I-136508
Status last verified
Jun 2014
First submitted
25 Feb 2009
Last updated
21 Jul 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, bortezomib and pegylated liposomal doxorubicin hydrochloride in people with Lymphoma, run by Roswell Park Cancer Institute at 1 site 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: stopped early, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21 (time frame: at weeks 9 and 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Jul 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT00851552 | AzTrials