Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer

June 5, 2013 updated by: National Cancer Institute (NCI)

A Phase I Trial Of Rituximab And Interleukin-2

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. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid malignancy.

Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population.

Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of intermediate-dose pulse aldesleukin.

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical 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

Inclusion Criteria:

  • Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder

    • Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
    • Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
  • No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
  • Measurable or evaluable disease
  • Must have failed standard curative therapy
  • No CNS or leptomeningeal metastasis
  • Performance status - Karnofsky 70-100%
  • Performance status - ECOG 0-1
  • At least 4 months
  • Absolute neutrophil count at least 1,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)
  • Platelet count at least 50,000/mm^3
  • AST no greater than upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • Creatinine no greater than ULN
  • No prior unstable coronary artery disease
  • No New York Heart Association class III or IV congestive heart failure
  • DLCO and FEV1 at least 50% of predicted
  • HIV negative
  • No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No infection requiring IV antibiotic therapy within the past 4 weeks
  • No other major illness that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • See Disease Characteristics
  • Prior antibody therapy allowed
  • Prior interleukin-2 or interferon alfa allowed
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • At least 4 weeks since prior systemic corticosteroids
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior surgery

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (rituximab and aldesleukin)
Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84.
Other: laboratory biomarker analysis
Correlative studies
Biological: rituximab
Given IV
Other Names:
  • Rituxan
  • Mabthera
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • MOAB IDEC-C2B8
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies
Biological: aldesleukin
Given SC
Other Names:
  • Proleukin
  • IL-2
  • recombinant human interleukin-2
  • recombinant interleukin-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0
Time Frame: 2 weeks
Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.
2 weeks

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Pierluigi Porcu, Ohio State University

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

December 1, 2000

Primary Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 6, 2013

Last Update Submitted That Met QC Criteria

June 5, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01404
  • U01CA076576 (U.S. NIH Grant/Contract)
  • 0037 (Registry Identifier: Southern University and A&M Colleges)
  • CDR0000068454
  • OSU-0037
  • NCI-130
  • OSU-00H0223

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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