NCT02339987

Brief Summary

Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

3.6 years

First QC Date

January 13, 2015

Last Update Submit

February 19, 2019

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

  • Evaluate Feasibility of conducting TIL procurement in a single-site setting

    Cell viability, viable number and TIL potency using standardized methods

    5 years

  • Evaluate Safety of conducting TIL procurement in a single-site setting

    lab personnel training during procurement, isolation, testing tumor reactivity and cryopreservation

    5 separate TIL procedures

Secondary Outcomes (1)

  • To determine whether TIL Procurement, isolation, testing tumor reactivity and cryopreservation can be performed at John Wayne Cancer Institute (JWCI) and Providence Saint John's Health Center (PSJHC) and infused into patients

    5 years

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cancer clinic

You may qualify if:

  • Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose.
  • Patients must be \> 15 years of age and must have metastatic melanoma.
  • Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery.
  • Patients must be able to understand and sign the Informed Consent document.
  • Patients must be able to complete the supplemental data form

You may not qualify if:

  • women who are pregnant or breastfeeding
  • inability to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue from resection of a metastatic melanoma lesion

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Santosh Kesari, MD, PhD

    Saint John's Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

November 1, 2014

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

February 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)