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Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma

NCT01875653 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-05-10

No results posted yet for this study

Summary

The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy.

This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study therapy") because it is not yet approved by the U.S. Food and Drug Administration (FDA). This research study will use the patient's own tumor cells,the patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a standard treatment to help increase the number of white blood cells after chemotherapy.

The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the growth factor. The resulting solution is called the study therapy. The intent of the study therapy is to make the dendritic cells more effective at fighting the tumor when they are injected back into the patient.

Conditions

  • Stage IV Melanoma
  • Stage III Melanoma

Interventions

BIOLOGICAL

Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)

Comparison of a cancer treatment containing patient specific irradiated tumor cells mixed with antigen presenting immune cells suspended in an immune system stimulant vs. a cancer treatment containing patient specific immune cells suspended in an immune system stimulant

BIOLOGICAL

Autologous PBMCs in GM-CSF (MC)

Comparison of a cancer treatment containing patient specific irradiated tumor cells mixed with antigen presenting immune cells suspended in an immune system stimulant vs. a cancer treatment containing patient specific immune cells suspended in an immune system stimulant

Sponsors & Collaborators

  • Lisata Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert O Dillman, MD · Caladrius Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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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 NCT01875653 on ClinicalTrials.gov