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In Vivo Persistence of Adoptively-Transferred TIL Cultured With Akti in People With Metastatic Melanoma

NCT02489266 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-07-27

No results posted yet for this study

Summary

Background:

\- One cancer therapy involves taking white blood cells from a person, changing them in a lab, and then giving the cells back to the person. These cells are called tumor infiltrating lymphocytes (TIL). Researchers want to grow some of the TIL cells with the drug Akti to see if they live longer than those grown without it.

Objectives:

\- To see if TIL cells grown with Akti live longer than those grown without it.

Eligibility:

\- Adults 18 70 with metastatic melanoma

Design:

* Participants will:
* Be screened with tests including scans, x-rays, heart and lung tests, blood and urine tests, and a \<TAB\>possible colonoscopy.
* Have tumor surgery or biopsy.
* Have a large catheter inserted into a vein in the upper chest.
* Receive leukapheresis for 4 5 hours. Blood is removed through a needle in an arm. White blood cells \<TAB\>are removed. The rest of the blood is returned by needle in the other arm.
* The cells will be changed in a laboratory.
* Participants will check into the hospital and:
* For 5 days, get 1 2 chemotherapy drugs by catheter.
* For 1 3 days, get the changed cells by catheter.
* For several days, get 2 drugs to stimulate cells, one by injection, the other by catheter.
* For 7 12 days, recover in the hospital.
* After treatment, participants will:
* Take an antibiotic and antiviral for at least 6 months.
* Return to NIH for several 2-day visits for a few years. At each visit, participants will have lab tests, imaging studies, and a physical exam. At some visits, they may have leukapheresis or blood tests.

Conditions

Interventions

BIOLOGICAL

AKTi-treated TIL

On day 0, cells will be infused intravenously (IV) over 20-30 minutes (between 1 and 4 days after the last dose of fludarabine).

DRUG

Cyclophosphamide

Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days.

DRUG

Fludarabine

Patients will receive Fludarabine 25 mg/m2/day for 5 days.

DRUG

Aldesleukin

Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Steven A Rosenberg, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-24
Primary Completion
2016-06-29
Completion
2016-06-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489266 on ClinicalTrials.gov