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Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008
First Received: December 11, 2006   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00411086
  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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma.

PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Biological: sargramostim
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults

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

Primary Outcome Measures:
  • Complete response at 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival at 3 years [ Designated as safety issue: No ]
  • Overall response rate [ Designated as safety issue: No ]
  • Adverse event profile [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: November 2006
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and efficacy of rituximab and sargramostim (GM-CSF), in terms of complete response at 12 weeks, in patients with newly diagnosed follicular B-cell lymphoma.

Secondary

  • Determine the overall response rate in patients treated with this regimen.
  • Determine the progression-free survival at 3 years in patients treated with this regimen.
  • Determine the adverse event profile of this regimen in these patients.
  • Determine the survival of patients treated with this regimen.
  • Determine the effect of Fc gamma receptor polymorphism on response rate and time to progression in patients treated with this regimen.

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

Patients receive rituximab IV on days 1, 8, 15, and 22 and sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5. Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 52 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:

  • Histologically confirmed newly diagnosed follicular B-cell lymphoma

    • CD20-positive disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to rituximab or other agents (e.g., sargramostim [GM-CSF] or yeast-derived components of the recombinant) used in the study
  • No known anaphylaxis or IgE-mediated hypersensitivity to murine proteins
  • No uncontrolled intercurrent illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would preclude study compliance
  • No evidence of active or prior infection with hepatitis B

    • Patients vaccinated for hepatitis B who have positive antibodies allowed

PRIOR CONCURRENT THERAPY:

  • No prior therapy for follicular B-cell lymphoma
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent steroids, including dexamethasone or other glucocorticoids
  • No concurrent pegfilgrastim or other long-acting colony-stimulating factor
  • No concurrent cytotoxic therapy
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411086

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Peter W. McLaughlin, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M. D. Anderson Cancer Center at University of Texas ( Peter W. McLaughlin )
Study ID Numbers: CDR0000521620, MDA-2006-0260
Study First Received: December 11, 2006
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00411086     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
Immunologic Factors
B-cell Lymphomas
Rituximab
Lymphoma, Follicular
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Follicular Lymphoma
Lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 06, 2009