search
Back to results

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

Primary Purpose

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interleukin-12
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (interleukin-12)

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate
Simon's two-stage model will be used.

Secondary Outcome Measures

Toxicity as assessed by CTC version 2.0

Full Information

First Posted
November 1, 1999
Last Updated
April 14, 2015
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003210
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (interleukin-12)
Arm Type
Experimental
Arm Description
Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
recombinant interleukin-12
Other Intervention Name(s)
cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472
Intervention Description
Given subcutaneously
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate
Description
Simon's two-stage model will be used.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Toxicity as assessed by CTC version 2.0
Time Frame
Up to 5 years after completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs