NCT02327390

Ex Vivo-Activated Lymph Node Lymphocytes in Treating Patients With Stage IIIC-IV Melanoma

Terminated Phase 1 Last updated 6 December 2018

What this trial tests

Phase 1 trial testing lymph node in Stage IIIC Skin Melanoma in 3 participants. Terminated before completion.

Timeline

17 March 2015

Primary endpoint
18 July 2016

18 July 2016

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	17 March 2015
Primary completion	18 July 2016
Estimated completion	18 July 2016
Sites	1 location across United States

Drugs / interventions tested

• lymph node
• X-ACT — full drug profile →

Conditions studied

• Stage IIIC Skin Melanoma — all drugs for Stage IIIC Skin Melanoma →
• Stage IV Melanoma — all drugs for Stage IV Melanoma →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Stage IIIC Skin Melanoma or Stage IV Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the safety and best dose of ex-vivo activated lymph node lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's lymph node(s) close to a melanoma tumor. These lymph nodes contain special kind of cells (called T cells) which can be activated (getting the cells to start up certain responses in the immune system) outside of the body in an approved laboratory. The activated T cells are then injected back into the same participant using an i.v. to help the participant's immune system to target melanoma. The participant will undergo regular blood testing to determine whether the X-ACT treatment has resulted in changes to the immune system and also whether the T cells which were given back to the patient persist in the blood stream over time. In addition, the effect of the X-ACT treatment on the growth or shrinkage of the participant's melanoma will be measured.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial Watch: Adoptively transferred cells for anticancer immunotherapy.
   Fournier C, Martin F, Zitvogel L, Kroemer G, et al · · 2017 · cited 55× · PMID 29147628 · DOI 10.1080/2162402x.2017.1363139
2. Trial Watch: Adoptive cell transfer for oncological indications.
   Aranda F, Buqué A, Bloy N, Castoldi F, et al · · 2015 · cited 28× · PMID 26451319 · DOI 10.1080/2162402x.2015.1046673