Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin’s Lymphoma or Hodgkin’s Disease

Brief Title

Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease

Official Title

A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease

Brief Summary

      Phase II trial to study the effectiveness of interleukin-12 in treating patients with
      previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor
      cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to
      kill lymphoma cells.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Determine the response rate of interleukin-12 in previously treated patients with
      non-Hodgkin's lymphoma or Hodgkin's disease.

      II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL)
      expression on patients' peripheral blood lymphocytes.

      OUTLINE: Patients are stratified according to disease characteristics: low grade
      non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and
      variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large,
      diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.

      Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks
      in the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Response rate

Secondary Outcome

 Toxicity as assessed by CTC version 2.0

Condition

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Intervention

recombinant interleukin-12

Study Arms / Comparison Groups

 Treatment (interleukin-12)

Description:  Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

February 1998

Completion Date

November 2003

Primary Completion Date

November 2003

Eligibility Criteria

        Inclusion Criteria:

          -  Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and
             Burkitt's lymphoma) or Hodgkin's disease

          -  Maximum of 4 previous treatment regimens

          -  Measurable disease

          -  No CNS involvement

          -  Performance status - Zubrod 0-1

          -  Performance status - Karnofsky 80-100%

          -  At least 12 weeks

          -  Platelet count at least 75,000/mm^3

          -  Absolute neutrophil count greater than 1500/mm^3

          -  Lymphocyte count greater than 500/mm^3

          -  Hemoglobin at least 8.0 g/dL

          -  Bilirubin less than 1.5 mg/dL

          -  SGOT/SGPT less than 2 times normal

          -  Creatinine no greater than 1.6 mg/dL

          -  Creatinine clearance at least 60 mL/min

          -  No severe cardiovascular disease including active ischemic heart disease, congestive
             heart failure, or major arrhythmias

          -  No severe pulmonary disease including dyspnea with moderate to severe exertion

          -  HIV negative

          -  No active infection

          -  Not pregnant or nursing

          -  Fertile patients must use adequate contraception

          -  No clinically significant autoimmune disease (e.g. rheumatoid arthritis)

          -  No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer

          -  No prior allogeneic bone marrow or stem cell transplant

          -  At least 3 weeks since prior biologic therapy for lymphoma

          -  At least 3 weeks since prior chemotherapy for lymphoma

          -  No concurrent steroid therapy

          -  At least 3 weeks since prior endocrine therapy for lymphoma

          -  At least 3 weeks since prior radiotherapy for lymphoma

          -  At least 2 weeks since prior surgery

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anas Younes, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00003210

Organization ID

NCI-2012-02264

Secondary IDs

NCI-2012-02264

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Anas Younes, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

January 2013