Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma
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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 |
Biological: denileukin diftitox Biological: rituximab Other: flow cytometry Other: immunoenzyme technique Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Trial of Denileukin Diftitox in Combination With Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma |
- 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 ]
- 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 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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 |
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
Show 165 Study Locations| 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
Additional Information:
Publications:
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00460109 History of Changes |
| Other Study ID Numbers: | CDR0000539551, NCCTG-N0682 |
| Study First Received: | April 11, 2007 |
| Last Updated: | August 22, 2012 |
| Health Authority: | United States: Federal Government |
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Denileukin diftitox Rituximab Interleukin-2 |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Immunologic Factors Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013