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LymphomaPhase 1/2NCT00244985

Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1/2 study testing rituximab and pegylated liposomal doxorubicin hydrochloride in people with Lymphoma, run by Roswell Park Cancer Institute at 1 site 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: Monoclonal antibodies, such as rituximab, 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. 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 and pegylated liposomal doxorubicin hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Sep 2005to Dec 2012
Phase
Phase 1/2
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) subtypes:
  • Grade 1-3 follicular lymphoma
  • Mantle cell lymphoma
  • Small lymphocytic lymphoma
  • Diffuse large B-cell lymphoma
  • Diffuse mixed cell lymphoma
  • Marginal zone lymphoma
  • Relapsed or refractory CD20-positive disease
  • Measurable disease
  • Must have received ≥ 1 but < 4 prior standard chemotherapy regimens
  • No Burkitt's lymphoma or precursor B-lymphoblastic lymphoma
  • No CNS lymphoma

PATIENT CHARACTERISTICS:

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin > 7 g/dL

Hepatic

  • AST or ALT < 2 times upper limit of normal (unless due to primary disease)
  • Bilirubin ≤ 2 mg/dL

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • LVEF ≥ 50% by MUGA and/or 2-D echocardiogram
  • No history of New York Heart Association class II-IV cardiac disease
  • No congestive heart failure

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No uncontrolled active bacterial, viral, or fungal infection
  • No other serious disease that would preclude study participation
  • No other primary malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • Prior immunotherapy, including rituximab or other monoclonal antibody, allowed

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy and recovered
  • No prior doxorubicin (or equivalent anthracycline) at a cumulative dose > 400 mg/m^2
  • No other concurrent chemotherapy

Endocrine therapy

  • Nonsteroidal hormones for nonlymphoma-related conditions (e.g., insulin for diabetes) allowed
  • No concurrent corticosteroids except for a transient inflammatory reaction (i.e., skin rash or hives)

Radiotherapy

  • Recovered from prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • More than 4 weeks since prior major surgery (other than diagnostic surgery) and recovered

Other

  • No other concurrent antitumor 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 I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety, including qualitative and quantitative toxic effects and their duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's lymphoma.

Secondary

  • Determine the efficacy, including overall response rate and durability of objective response, of this regimen in these patients.
  • Correlate pretreatment functional, phenotypic, and genotypic characteristics of host immune effector cells with response in patients treated with this regimen.

OUTLINE: This is an open-label, pilot study.

Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Conditions
Lymphoma
Being tested
rituximab, pegylated liposomal doxorubicin hydrochloride
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent small lymphocytic lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • rituximabBiological

    IV

  • pegylated liposomal doxorubicin hydrochlorideDrug

    IV

Study groups in NCT00244985
Study groupRoleWhat they receive
Arm 1: Rituximab and Doxorubicin HCI LiposomeExperimentalPatients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
Receives: Biological: rituximab; Drug: pegylated liposomal doxorubicin hydrochloride

What is being measured

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

  1. Complete Response Rate at 20 Weeks

    Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.

    Measured: 20 weeks

Secondary outcomes (4)

  1. Partial Response Rate at 20 Weeks

    Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.

    Measured: 20 weeks

  2. Overall Response Rate (Complete and Partial Responses) at 20 Weeks

    Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes > 1.5 before therapy. Partial Response (PR): A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the > or = to 50% decrease. Additionally, no appearance of new lesions is noted.

    Measured: 20 weeks

  3. Progression Free Survival (PFS) Rate at 2 Years

    Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions.

    Measured: 2 years

  4. Overall Survival (OS) Rate at 2 Years

    Overall survival was defined as time from date of treatment initiation until date of death due to any cause.

    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 posted27 Oct 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionAug 2008
  4. Study completionDec 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00244985
Sponsor's protocol ID
CDR0000447130
Other IDs
RPC 02-04
Status last verified
Jul 2017
First submitted
25 Oct 2005
Last updated
17 Aug 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing rituximab 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: finished, as of the sponsor's last update on 17 Aug 2017. 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 combined 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.

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 14 Jul 2017). 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?

Complete Response Rate at 20 Weeks (time frame: 20 weeks). 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 NCT00244985.

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 17 Aug 2017.

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