Interleukin-12 Plus Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

August 2, 2011 updated by: Mayo Clinic

Phase I Study of Interleukin-12 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma

RATIONALE: Interleukin-12 may stimulate a person's white blood cells to kill lymphoma cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus rituximab in treating patients who have non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the optimal immunological dose of interleukin-12 and rituximab when administered in combination in patients with non-Hodgkin's lymphoma. II. Determine the toxicities associated with this regimen in this patient population. III. Assess the pharmacodynamics of this regimen in these patients. IV. Document observed clinical response to this regimen in these patients.

OUTLINE: This is a dose escalation study of interleukin-12. Patients receive rituximab IV on days 1, 8, 15, and 22. The first cohort of patients receives interleukin-12 SC twice weekly beginning on day 29. Subsequent cohorts receive interleukin-12 SC twice weekly beginning on day 16. Patients with stable or responding disease may continue treatment with interleukin-12 twice weekly for up to 24 weeks or until disease progression. Cohorts of 6-9 patients receive escalating doses of interleukin-12 until the optimal immunological dose is determined. The optimal immunological dose is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose limiting toxicities or the dose at which there is a maximal increase in gamma interferon, inducible protein-10 (IP-10) and immune cell infiltration into the lymphoma (whichever dose is lower). Following initial dose escalation, 2 additional cohorts of 6 patients receive a fixed dose of interleukin-12 SC twice weekly beginning on day 2. Patients are followed every 3 months for the first year, and then every 6 months for the next 4 years or until disease progression.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-13 months.

Study Type

Interventional

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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: Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma No relapsed intermediate or high grade disease eligible for bone marrow or stem cell transplant Intermediate or high grade disease must have received a prior anthracycline containing regimen Low grade disease (with or without prior therapy) felt to be incurable with standard therapy allowed No CNS involvement by lymphoma 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 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST/ALT less than 3 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No history of angina Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No uncontrolled infection No autoimmune related phenomena No peptic ulcer disease

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since prior rituximab No prior interleukin-12 No other concurrent immunotherapy Chemotherapy: See Disease Characteristics No prior fludarabine or 2-chlorodeoxyadenosine unless CD4 count normal Recovered from prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent steroid therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified

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

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Stephen M. Ansell, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 1999

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

June 17, 2004

First Posted (Estimate)

June 18, 2004

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067514
  • U01CA069912 (U.S. NIH Grant/Contract)
  • 980112 (Other Identifier: Mayo Clinic Cancer Center)

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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