Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma

July 17, 2013 updated by: Memorial Sloan Kettering Cancer Center

An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
  • Determine the 2-year progression-free survival of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.
  • Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen.

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

Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes:

    • Diffuse large cell lymphoma
    • Diffuse mixed cell lymphoma
    • Immunoblastic large cell lymphoma
  • CD20+ disease
  • Measurable progressive or refractory disease
  • No primary CNS lymphoma or lymphomatous meningitis 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

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Lymphocyte count less than 20,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9.5 g/dL

Hepatic

  • SGOT and SGPT no greater than 1.5 times upper limit of normal
  • Bilirubin normal
  • No liver disease

  • Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following:

    • Undetectable hepatitis C viral loads
    • Biopsy showing no active disease
    • Normal transaminases on at least 3 different occasions within the past year

Renal

  • Creatinine normal

Cardiovascular

  • No clinically significant cardiac dysfunction
  • No myocardial infarction within the past 6 months
  • No heart failure within the past 6 months

Pulmonary

  • No clinically significant pulmonary dysfunction
  • Patients with prior radiotherapy to the lung or autologous transplantation must have FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No significant infections within the past 2 weeks (including pneumonia or bronchitis)
  • No history of autoimmune disease
  • No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other solid tumor curatively treated with no evidence of recurrence within the past 2 years
  • No symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism
  • No prior type 1 hypersensitivity or anaphylactic reactions to murine products, rituximab, or radioimmunoconjugated anti-CD20 antibody infusion

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 months since prior autologous bone marrow transplantation
  • No prior allogeneic bone marrow transplantation
  • No prior interleukin-2
  • No prior interferon (alfa, beta, or gamma)
  • No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3

Chemotherapy

  • More than 30 days since prior chemotherapy
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • More than 2 weeks since prior systemic steroids
  • No concurrent systemic corticosteroids

Radiotherapy

  • More than 30 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • More than 30 days since prior major surgery

Other

  • More than 30 days since other prior investigational drugs
  • More than 30 days since prior immunosuppressive medications

  • No concurrent immunosuppressive medications including the following:

    • Cyclosporine
    • Mycophenolate mofetil
    • Tacrolimus
    • Sirolimus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Tarun Kewalramani, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

July 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIR-IL2005-A01
  • MSKCC-03004
  • CDR0000298986 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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