Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

Summary

Background:

* The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with melanoma.
* In this trial, we are determining if there is a difference in the response between patients who have received prior anti-programmed cell death-1 (PD-1) treatment to those who have not received this prior ant-PD1 treatment.

Objectives:

\- To determine if there is a difference in the rate of response between patients who have received prior anti-PD1 and those who have not.

Eligibility:

\- Individuals at least 18 years and less than or equal to 70 years of age who have metastatic melanoma.

Design:

* Work up stage: Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white blood cells. White blood cells will be grown from the tumor in the laboratory.
* Leukapheresis: Participants will have leukapheresis to collect additional white blood cells. (Leukapheresis is a common procedure which removes only the white blood cells from the patient.)
* Treatment: Participants will receive standard dose chemotherapy to prepare their immune system to accept the white blood cells. Participants will receive an infusion of their own white blood cells grown from tumor. They will also receive aldesleukin for up to five days to boost the immune system s response to the white blood cells. They will stay in the hospital for about 4 weeks for the treatment.
* Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.

Conditions

• Metastatic Melanoma

Interventions

DRUG

Aldesleukin

720,000 IU/kg intravenous (IV) every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses).

DRUG

Fludarabine

25 mg/m\^2/day intravenous piggy-back (IVPB) daily for 5 days

DRUG

Fludarabine

30 mg/kg/day intravenous piggy-back (IVPB) daily for 3 days.

DRUG

Cyclophosphamide

60 mg/kg/day X 2 days intravenous (IV)

DRUG

Cyclophosphamide

Days -5 to -3 (low-dose arm):30 mg/kg IV over 60 minutes for 2 days

DRUG

Cyclophosphamide

Days -5 to -3 (low-dose arm): 300 mg/m\^2 IV over 60 minutes.

BIOLOGICAL

Young TIL

Day 0: Cells will be infused intravenously (IV)

DRUG

Pembrolizumab

2 mg/kg intravenous (IV) on Days -2, 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days).

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Stephanie L Goff, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-12

Primary Completion

2021-10-14

Completion

2022-07-06

FDA Drug

Yes

Countries

• United States

Study Locations