MelanomaNCT02339987
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration
An observational study of Melanoma, run by Saint John's Cancer Institute at 1 site in United States.
Trial summary
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL) Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Melanoma
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 4 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cancer clinic
Who may be able to join
- 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
Who cannot join
- women who are pregnant or breastfeeding
- inability to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)
Read the detailed description
The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Feasibility of conducting TIL procurement in a single-site setting
Cell viability, viable number and TIL potency using standardized methods
Measured: 5 years
Evaluate Safety of conducting TIL procurement in a single-site setting
lab personnel training during procurement, isolation, testing tumor reactivity and cryopreservation
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startNov 2014
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Why it stopped: original PI left institute, no plan to continue using samples
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santosh Kesari, MD, PhD, Principal investigator, Saint John's Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339987
- Sponsor's protocol ID
- TIL-PROCURE-0614
- Status last verified
- Feb 2019
- First submitted
- 13 Jan 2015
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration
- ClinicalTrials.gov ID
- NCT02339987
- Acronym / sponsor ID
- TIL-PROCURE-0614
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: original PI left institute, no plan to continue using samples
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)
Detailed description
The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cancer clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- women who are pregnant or breastfeeding
- inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate Feasibility of conducting TIL procurement in a single-site setting
Time frame: 5 years
Cell viability, viable number and TIL potency using standardized methods
Evaluate Safety of conducting TIL procurement in a single-site setting
Time frame: 5 separate TIL procedures
lab personnel training during procurement, isolation, testing tumor reactivity and cryopreservation
1 secondary outcome
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
Time frame: 5 years
Results and safety
The study was stopped early (reason given: original PI left institute, no plan to continue using samples). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santosh Kesari, MD, PhD principal investigator
Saint John's Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Saint John's Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: original PI left institute, no plan to continue using samples). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Feasibility of conducting TIL procurement in a single-site setting (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.