NCT00003210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

August 13, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

April 15, 2015

Status Verified

January 1, 2013

Enrollment Period

5.8 years

First QC Date

November 1, 1999

Last Update Submit

April 14, 2015

Conditions

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueNodal Marginal Zone B-cell LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaSplenic Marginal Zone LymphomaWaldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Simon's two-stage model will be used.

    Up to 5 years

Secondary Outcomes (1)

  • Toxicity as assessed by CTC version 2.0

    Up to 5 years after completion of study treatment

Study Arms (1)

Treatment (interleukin-12)

EXPERIMENTAL

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-12Other: laboratory biomarker analysis

Interventions

recombinant interleukin-12BIOLOGICAL

Given subcutaneously

Also known as: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472
Treatment (interleukin-12)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (interleukin-12)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZoneLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom Macroglobulinemia

Interventions

Interleukin-12 Subunit p35Interleukin-12

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Anas Younes

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 13, 2003

Study Start

February 1, 1998

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

April 15, 2015

Record last verified: 2013-01

Locations

US(1)