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Rituximab and Dexamethasone in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: October 25, 2005   Last Updated: February 6, 2009   History of Changes
Sponsored by: Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00244855
  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 dexamethasone, 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 dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with dexamethasone works in treating patients with B-cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: dexamethasone
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Rituximab Dexamethasone Sodium Phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Evaluating the Efficacy of Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma

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

Primary Outcome Measures:
  • Clinical response rate at 3 and 6 months [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Grade II-IV and grade III-IV infusion-related toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis compared with clinical response at baseline, 4 weeks, and 3 months [ Designated as safety issue: No ]
  • Soluble CD20 fragments or CD20-containing membrane fragments and clinical response compared at baseline, 4 weeks, and 3 months [ Designated as safety issue: No ]
  • Phenotype analysis of CD16 and CD32 on natural killer cells compared with clinical response [ Designated as safety issue: No ]
  • Rituximab pharmacokinetics and clinical response compared at baseline, 4 weeks, and 3 months [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: January 2005
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the clinical response rate and progression-free survival at 3 and 6 months in patients with CD20-positive low-grade B-cell non-Hodgkin's lymphoma treated with rituximab and dexamethasone.
  • Determine the rates of grade II-IV and grade III-IV toxicity of this regimen in these patients.

Secondary

  • Correlate the antibody dependent cell mediated cytotoxicity, effector cell phenotype analysis, and soluble CD20 fragments or CD20-containing membrane fragments at baseline, 4 weeks, and 3 months with clinical response in patients treated with this regimen.
  • Correlate phenotype analysis of CD16 and CD32 on natural killer cells with clinical response in patients treated with this regimen.
  • Correlate rituximab pharmacokinetics at baseline, 4 weeks, and 3 months with clinical response in patients treated with this regimen.

OUTLINE: This is multicenter study.

Patients receive dexamethasone IV over 30 minutes and rituximab IV once weekly for 4 weeks in the absence of unacceptable toxicity. Patients with progressive disease at the 6-month follow-up visit may be retreated on this protocol with dexamethasone and rituximab.

After completion of study treatment, patients are followed at 3 and 6 months and then every 6 months until disease progression.

PROJECTED ACCRUAL: Approximately 40-96 patients (20-52 with previously treated or relapsed disease and 20-44 with previously untreated disease) will be accrued for this study within 2-3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma, including any of the following subtypes:

    • Follicular lymphoma
    • Marginal zone lymphoma
    • Monocytoid B-cell lymphoma
    • Lymphoplasmacytoid lymphoma
  • The following diagnoses are not allowed:

    • Intermediate- or high-grade non-Hodgkin's lymphoma
    • Mantle cell lymphoma
    • Chronic lymphocytic leukemia
    • Small lymphocytic lymphoma
  • CD20-positive disease
  • Previously untreated or relapsed disease
  • Measurable disease with clearly defined margins, defined as ≥ 1 lesion ≥ 20 mm by conventional CT scan or MRI OR ≥ 10 mm by spiral CT scan
  • No active CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.

However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Hemoglobin > 7 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST or ALT ≤ 2 times upper limit of normal
  • No active hepatitis B or other hepatitis viral infection
  • No hepatitis C positive serology

Renal

  • Creatinine ≤ 2.5 mg/dL

Cardiovascular

  • No New York Heart Association class III or IV heart disease

Pulmonary

  • No requirement for supplemental oxygen

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after completion of study treatment
  • No known HIV positivity
  • No active infection requiring antimicrobial therapy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 6 months since prior rituximab

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 1 month since prior systemic steroid therapy

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244855

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Puget Sound Oncology Consortium at Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: David G. Maloney, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center ( David G. Maloney )
Study ID Numbers: CDR0000441527, PSOC-2002, GENENTECH-PSOC-2002, PSOC-IRB-5794
Study First Received: October 25, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00244855     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
contiguous stage II marginal zone lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
splenic marginal zone lymphoma
stage I marginal zone lymphoma
stage III marginal zone lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
Waldenstrom macroglobulinemia
nodal marginal zone B-cell lymphoma

Study placed in the following topic categories:
Dexamethasone
Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Lymphoma, Follicular
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Lymphoma, B-Cell, Marginal Zone
Follicular Lymphoma
Hormones
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Lymphoma
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Rituximab
Glucocorticoids
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
B-cell Lymphomas
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Lymphoma, Follicular
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Lymphoma, B-Cell
Therapeutic Uses
Lymphoma
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Rituximab
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009