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Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00460109
  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. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin diftitox works in treating patients with previously untreated stage III or stage IV follicular B-cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: denileukin diftitox
Drug: rituximab
Procedure: flow cytometry
Procedure: immunoenzyme technique
Procedure: laboratory biomarker analysis
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Rituximab    Denileukin diftitox   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Clinical Trial of Denileukin Diftitox in Combination With Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma

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

Primary Outcome Measures:
  • Proportion of confirmed tumor response (complete response [CR], unconfirmed CR, and partial response) [ Designated as safety issue: No ]
  • Proportion of successes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to subsequent therapy [ Designated as safety issue: No ]
  • Changes in immunologic parameters [ Designated as safety issue: No ]
  • Incidence of immune responses [ Designated as safety issue: No ]

Estimated Enrollment:   53
Study Start Date:   April 2008
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate (complete response [CR], unconfirmed CR, and partial response) in patients with previously untreated stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with rituximab and denileukin diftitox.
  • Assess the overall survival, time-to-progression, duration of response, and time-to-new therapy in patients treated with this regimen.

Secondary

  • Determine whether this regimen depletes or inhibits the function of regulatory T cells in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients also receive denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Blood is collected at baseline; on day 1 of courses 2-4; and 1 and 4 months after completion of study treatment for research studies. Research studies include analysis of peripheral blood lymphocyte subsets expressing CD3, CD4, CD8, CD19, CD25, and CD26 by flow cytometry; quantitation of CD4+, CD25+ regulatory T cells by flow cytometry; tumor-specific γ-interferon-secreting T cells by enzyme-linked immunospot assay; tumor-specific cytotoxic T-lymphocyte activity; and immune activation by enzyme-linked immunosorbent assay.

After completion of study treatment, patients are followed periodically for up to 5 years after registration.

PROJECTED ACCRUAL: A total of 53 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:

  • Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

    • Stage III or IV disease
    • Grade 1 or 2 disease
  • Previously untreated disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques

    • Clearly defined bidimensional diameter ≥ 2 x 2 cm on physical examination OR > 2.0 cm in 1 of the dimensions by CT scan, MRI, or plain radiograph imaging
    • Splenic enlargement may be used as a measurable parameter if the spleen is palpable ≥ 3 cm below the left costal margin
  • Circulating tumor cells < 5,000/mm³
  • Must have paraffin-embedded tissue blocks/slides available
  • No CNS lymphoma

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 1 year
  • WBC ≥ 3,400/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 times ULN
  • AST ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Albumin ≥ 3 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after completion of study therapy
  • No HIV infection
  • No other active malignancies
  • No active uncontrolled infection
  • No known hypersensitivity to denileukin diftitox or any of its components, including diphtheria toxin, aldesleukin, or excipients

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy, immunotherapy, vaccines, or radiotherapy for NHL
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460109

Show 77 study locations  Show 77 Study Locations

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Stephen M. Ansell, MD, PhD     Mayo Clinic    
Investigator:     Thomas E. Witzig, MD     Mayo Clinic    
Investigator:     Peter T. Silberstein, MD     Creighton University Medical Center    
  More Information

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

Study ID Numbers:   CDR0000539551, NCCTG-N0682
First Received:   April 11, 2007
Last Updated:   August 28, 2008
ClinicalTrials.gov Identifier:   NCT00460109
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage IV grade 1 follicular lymphoma  
stage IV grade 2 follicular lymphoma  

Study placed in the following topic categories:
Immunoproliferative Disorders
Rituximab
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell
Lymphatic Diseases
Interleukin-2
B-cell lymphomas
Denileukin diftitox
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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