Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma

Phase 3

Terminated

• Conditions: Stage IV Melanoma; Stage III Melanoma
• Interventions: Biological: Autologous PBMCs in GM-CSF (MC); Biological: Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)

• Registration Number: NCT01875653
• Lead Sponsor: Lisata Therapeutics, Inc.

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 Description

Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window.

Study Timeline

• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-12
• Study Start: 2014-10
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous PBMCs in GM-CSF (MC)	Autologous PBMCs in GM-CSF (MC)	DOSE/ROUTE/REGIMEN: 1. Treatment Duration: Doses of MC will be administered subcutaneously weekly for 3 consecutive weeks, then monthly for the next 5 months. 2. Dosage: Each dose of MC contains approximately 10 million cells. Each dose is suspended in 500 mcg GM-CSF prior to administration. 3. Mode of Administration: Subcutaneous (SC) injections.
Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)	Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)	DOSE/ROUTE/REGIMEN: 1. Treatment Duration: Doses of DC-TC will be administered subcutaneously weekly for 3 consecutive weeks, then monthly for the next 5 months. 2. Dosage: Each dose of DC-TC contains approximately 10-20 million cells. Each dose is suspended in 500 mcg GM-CSF prior to administration. 3. Mode of Administration: Subcutaneous (SC) injections.

Primary Outcome Measures

Name	Time	Method
Overall survival	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events as a Measure of Safety and Tolerability	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