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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00244985
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : July 14, 2017
Last Update Posted : August 17, 2017
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: pegylated liposomal doxorubicin hydrochloride Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Rituximab and Doxorubicin HCI Liposome
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
 Biological: rituximab
IV

Drug: pegylated liposomal doxorubicin hydrochloride
IV


Outcome Measures
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Primary Outcome Measures :
  1. Complete Response Rate at 20 Weeks [ Time Frame: 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.


Secondary Outcome Measures :
  1. Partial Response Rate at 20 Weeks [ Time Frame: 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.

  2. Overall Response Rate (Complete and Partial Responses) at 20 Weeks [ Time Frame: 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.

  3. Progression Free Survival (PFS) Rate at 2 Years [ Time Frame: 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.

  4. Overall Survival (OS) Rate at 2 Years [ Time Frame: 2 years ]
    Overall survival was defined as time from date of treatment initiation until date of death due to any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244985


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Ortho Biotech, Inc.
Investigators
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Principal Investigator: Myron S. Czuczman, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00244985    
Other Study ID Numbers: CDR0000447130
RPC 02-04 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: October 27, 2005    Key Record Dates
Results First Posted: July 14, 2017
Last Update Posted: August 17, 2017
Last Verified: July 2017
Keywords provided by Roswell Park Cancer Institute:
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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Doxorubicin
Liposomal doxorubicin
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action