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Report for Clinical Trial NCT01875653

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma

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.

NCT01875653 Stage IV Melanoma Stage III Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

2 Interventions

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

Description: 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
Type: Biological
Group Labels: 2

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

Name: Autologous PBMCs in GM-CSF (MC)

Description: 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
Type: Biological
Group Labels: 1

Autologous PBMCs in GM-CSF (MC)


Primary Outcomes

Description: 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.

Measure: Overall survival

Time: 52 months

Secondary Outcomes

Description: 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

Measure: Adverse Events as a Measure of Safety and Tolerability

Time: 52 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

2. Patients with multiple depots of distant metastatic disease must have previously received at least one or more of the following standard treatments: interleukin 2 (IL-2), or ipilimumab, or vemurafenib (if tumor expresses the V600E mutation), or dacarbazine or temozolomide, if not mutated for the V600E mutation, and not felt to be medically appropriate for IL-2 or ipilimumab. --- V600E ---

2. Patients with multiple depots of distant metastatic disease must have previously received at least one or more of the following standard treatments: interleukin 2 (IL-2), or ipilimumab, or vemurafenib (if tumor expresses the V600E mutation), or dacarbazine or temozolomide, if not mutated for the V600E mutation, and not felt to be medically appropriate for IL-2 or ipilimumab. --- V600E --- --- V600E ---



HPO Nodes


HPO: