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Treating High Risk Leukemia With CD40 Ligand & IL-2 Gene Modified Tumor Vaccine

NCT00058799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-01-21

No results posted yet for this study

Summary

This research study is to determine the safety and dosage of special cells that may make the patients own immune system fight the leukemia. To do this we will put special genes into cells called fibroblasts that we have grown in the laboratory from a skin sample. The genes we put in these fibroblasts make them produce substances called CD40 Ligand (CD40L) and interleukin-2 (IL-2). These are natural substances that may help the immune system kill leukemia cells. Some of these fibroblasts producing CD40L and IL-2 mixed with a small quantity of the leukemic cells will then be put back into the body.

Studies of cancers in animals and in cell lines suggest that substances like CD40L and IL-2 when mixed with cancer cells do help the body to recognize and kill these cancer cells. A treatment using IL-2 has been previously used in more than 40 children with neuroblastoma and similar treatments are being used in adults with other cancers. Some of the patients have shown significant tumor responses. However, we do not know if this treatment will work and we do not know the right amount of each of the special cells to use, so different patients will get different combination and numbers of cells.

The purpose of this study is to learn the side effects and safe dosage of these special cells.

Conditions

Interventions

BIOLOGICAL

Dose Level 1

Leukemic Blasts 2 x 10\^7; IL-2 Fibroblasts 2 x 10\^7; CD40L Fibroblasts 2 x 10\^5

BIOLOGICAL

Dose Level 2

Leukemic Blasts 2 x 10\^7; IL-2 Fibroblasts 2 x 10\^7; CD40L Fibroblasts 2 x 10\^5

BIOLOGICAL

Dose Level 3

Leukemic Blasts 2 x 10\^7; IL-2 Fibroblasts 2 x 10\^7; CD40L Fibroblasts 4.2 x 10\^7

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Malcolm K Brenner, MD, PhD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00058799 on ClinicalTrials.gov