Rituximab and Pegfilgrastim in Treating Patients With Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified November 2012 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524628
First received: August 31, 2007
Last updated: November 27, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. Pegfilgrastim may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with pegfilgrastim may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with pegfilgrastim works in treating patients with non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: pegfilgrastim Biological: rituximab Other: flow cytometry Other: immunohistochemistry staining method |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Overall response rate at weeks 11, 27, and 43 [ Time Frame: AT Weeks 11, 27, 43 ] [ Designated as safety issue: No ]AT Weeks 11, 27, 43
Secondary Outcome Measures:
- Complete response at weeks 11, 27, and 43 [ Time Frame: AT Weeks 11, 27, 43 ] [ Designated as safety issue: No ]AT Weeks 11, 27, 43
- Partial response at weeks 11, 27, and 43 [ Time Frame: AT Weeks 11, 27, 43 ] [ Designated as safety issue: No ]AT Weeks 11, 27, 43
- Time to disease progression [ Time Frame: weeks 11,27 and 43 and after 4 months from completion of treatment ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Patients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Biological: pegfilgrastim
Subcutaneous
Biological: rituximab
Given IV
Other: flow cytometry
Correlative Study
Other: immunohistochemistry staining method
Correlative Study
|
Detailed Description:
OBJECTIVES:
Primary
- Evaluate the safety of rituximab and pegfilgrastim in patients with untreated or relapsed/recurrent follicular lymphoma, small lymphocytic lymphoma, or marginal zone lymphoma.
Secondary
- Evaluate the efficacy (including overall response rate and durability of objective responses) of this regimen in these patients.
- Evaluate functional and phenotypic characteristics of host neutrophils.
- Evaluate changes of CD20 antigen expression and density of expression.
- Evaluate changes in serum tumor necrosis factor (TNF), interferon alpha, and free radical levels.
OUTLINE: Patients receive rituximab IV once a week in weeks 1, 3, 5, 7, 15, 23, 31, and 39 and pegfilgrastim subcutaneously 3 days before receiving rituximab for a total of 8 doses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study treatment for correlative studies. Samples are analyzed for phenotype changes in neutrophils, oxidative burst, and cytokine levels by flow cytometry and in vitro functional assays. Patients with easily accessible lymphomatous lesions undergo excisional biopsy within 24 hours after completion of first dose of rituximab. Tissues are analyzed for infiltration of neutrophils into tumor bed, changes in CD20 expression by immunohistochemistry, flow cytometry, and western blot, and evidence of apoptosis.
After completion of study treatment, patients are followed every 4 months for 1 year, every 6 months for 2 years, and once at year 4.
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, B-cell non-Hodgkin lymphoma:
- Grade 1, 2, or 3a follicular lymphoma
- Small lymphocytic lymphoma
- Marginal zone lymphoma
Previously untreated, relapsed, or recurrent disease
- No limit to prior treatments
- CD20-positive disease
- Measurable tumor size, defined as at least 1 node measuring 4 cm² bidimensionally
- No premalignant myeloid condition
- No malignancy with myeloid characteristics (e. g., myelodysplastic syndrome, acute or chronic myelogenous leukemia)
- No CNS lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Expected survival > 6 months
- ANC > 1,000/mm³
- Platelet count > 50,000/mm³
- Hemoglobin ≥ 8 g/dL (erythropoietin growth factor allowed)
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL
- AST < 5 times ULN
- Alkaline phosphatase < 5 times ULN
- HIV-negative
- No serious nonmalignant disease (e.g., active uncontrolled bacterial, viral, or fungal infections) or other conditions that would compromise protocol objectives
- No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- No history of cardiac disease, defined as NYHA class II-IV cardiac disease
- No clinical evidence of congestive heart failure
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No know hypersensitivity to any recombinant E. coli-derived product, murine proteins, or any components of the study medication
PRIOR CONCURRENT THERAPY:
- Fully recovered from prior surgery, radiotherapy, chemotherapy, or immunotherapy
- Prior rituximab or other monoclonal immunotherapy allowed
- No chemotherapy within 4 weeks of the first scheduled study treatment
- No major surgery, other than diagnostic surgery, within the past 4 weeks
- More than 30 days since prior participation in another investigational device or drug trial
- No other concurrent investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524628
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Francisco J. Hernandez-Ilizaturri, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00524628 History of Changes |
| Other Study ID Numbers: | CDR0000562751, RPCI-I-83106 |
| Study First Received: | August 31, 2007 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
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 recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma recurrent small lymphocytic lymphoma 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 marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma nodal marginal zone B-cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013