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Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00244985
  Purpose

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 Intervention Phase
Lymphoma
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: rituximab
Phase I
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Rituximab Tositumomab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate at 20 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial response rate at 20 weeks [ Designated as safety issue: No ]
  • Overall response rate (complete and partial responses) at 20 weeks [ Designated as safety issue: No ]
  • Time to disease progression at 2 years [ Designated as safety issue: No ]
  • Survival at 2 years [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: September 2005
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244985

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Myron S. Czuczman, MD Roswell Park Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Roswell Park Cancer Institute ( Myron S. Czuczman )
Study ID Numbers: CDR0000447130, RPCI-RPC-0204
Study First Received: October 25, 2005
Last Updated: October 25, 2008
ClinicalTrials.gov Identifier: NCT00244985  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Mantle cell lymphoma
Doxorubicin
Recurrence
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Antibodies
Leukemia, Lymphocytic, Chronic, B-Cell
B-cell lymphomas
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009