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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00003210
Collaborator
(none)
105
1
1
69
1.5

Study Details

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

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease
Study Start Date :
Feb 1, 1998
Actual Primary Completion Date :
Nov 1, 2003
Actual Study Completion Date :
Nov 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (interleukin-12)

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

Biological: recombinant interleukin-12
Given subcutaneously
Other Names:
  • cytotoxic lymphocyte maturation factor
  • IL-12
  • interleukin-12
  • natural killer cell stimulatory factor
  • Ro 24-7472
  • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [Up to 5 years]

      Simon's two-stage model will be used.

    Secondary Outcome Measures

    1. Toxicity as assessed by CTC version 2.0 [Up to 5 years after completion of study treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00003210
    Other Study ID Numbers:
    • NCI-2012-02264
    • NCI-2012-02264
    • CDR0000066067
    • NCI-T97-0050
    • DM-97073
    • T97-0050
    • N01CM17003
    First Posted:
    Aug 13, 2003
    Last Update Posted:
    Apr 15, 2015
    Last Verified:
    Jan 1, 2013

    Study Results

    No Results Posted as of Apr 15, 2015