Completed

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

What is being tested

recombinant interleukin-12

+ laboratory biomarker analysis

BiologicalOther

Who is being recruted

Blood Protein Disorders+34

+ Cardiovascular Diseases

+ Chronic Disease

Over 16 Years

+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: February 1998

See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)

Last updated: April 15, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003210

Principal SponsorNational Cancer Institute (NCI)

Last updated: April 15, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

105 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesLeukemia, B-CellLymphoma, B-CellLymphoma, T-CellHemostatic DisordersDisease AttributesNeoplasms, Plasma CellHodgkin DiseaseLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-Cell

Criteria

30 inclusion criteria required to participate

Absolute neutrophil count greater than 1500/mm^3

At least 12 weeks

At least 2 weeks since prior surgery

At least 3 weeks since prior biologic therapy for lymphoma

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

M D Anderson Cancer Center

Houston, United StatesOpen M D Anderson Cancer Center in Google Maps

CompletedOne Study Center