Clinical Trial: Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous P

Brief 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.


Detailed Summary: Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window.
Sponsor: Caladrius Biosciences, Inc.

Current Primary Outcome: Overall survival [ Time Frame: 52 months ]

The time frames are estimated time in months (rounded up to the nearest month) from the start of study. The time estimates for the analyses are based on enrolling approximately 250 patients over a 34.8 months period and having a follow up of approximately 17 months after the last patient is enrolled.


Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 52 months ]

  • Adverse Events monitoring to assess safety and tolerability
  • History & physical examination, vital signs, clinical laboratory tests (safety), and other tests as clinically indicated adverse event monitoring to assess safety and toxicity


Original Secondary Outcome: Same as current

Information By: Caladrius Biosciences, Inc.

Dates:
Date Received: June 7, 2013
Date Started: October 2014
Date Completion: June 2022
Last Updated: April 25, 2016
Last Verified: January 2016