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Use of IL-15 After Chemotherapy and Lymphocyte Transfer in Metastatic Melanoma

NCT01369888 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-01-27

Study results available
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Summary

Background:

\- Researchers have developed an experimental cancer treatment called cell therapy. White blood cells called lymphocytes are taken from a tumor, grown in large numbers in the lab, and then given back to the patient. Interleukin-15, given to the patient after the cells (now called Young tumor-infiltrating lymphocytes of Young TIL cells) are replaced, helps the cells to grow and boosts the immune system. This process changes your normal cells into cells that are able to recognize your tumor has been studied in the lab. These cells can destroy tumor cells in the test tube, but scientists want to see if they work inside the body.

Objectives:

-To test the effectiveness of lymphocytes drawn from tumor cells combined with interleukin-15 in treating metastatic melanoma.

Eligibility:

* Patients must be 18 - 66 years of age and have a diagnosis of metastatic melanoma.
* They will have heart and lung function tests, lab tests, and imaging procedures.
* Patients may not have conditions such as active systemic infections, blood clotting disorders, or other active major medical illnesses.
* Patients may not be pregnant or nursing.

Conditions

Interventions

DRUG

Cyclophosphamide

60 mg/m\^2, intravenous (IV) (in the vein) x 2 days

DRUG

Fludarabine

25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)

BIOLOGICAL

Tumor Infiltrating Lymphocytes

IV over 30 minutes on day 0

DRUG

IL-15

IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01369888 on ClinicalTrials.gov