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Modified Tumor Infiltrating Lymphocytes for Metastatic Melanoma

NCT01369875 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-12-10

Study results available
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Summary

Background:

\- Tumor infiltrating lymphocytes (TIL) are white blood cells that have been taken from tumor tissue. The cells are modified to help them kill tumor cells, then given back to the person with cancer. By giving these cells to patients, researchers hope to improve the current treatments available for patients with melanoma that has not responded to standard therapies. The TIL will be given after treatments that will suppress the immune system. This makes it easier for the TIL to attack the cancer cells. The TIL will also be given with aldesleukin (IL-2), which is designed to help keep the TIL cells alive in the body.

Objectives:

\- To study the safety and effectiveness of specially modified tumor infiltrating lymphocytes to treat melanoma that has not responded to other treatments.

Eligibility:

\- Individuals at least 18 years of age who have metastatic melanoma that has not responded to other treatments.

Design:

* Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies.
* A piece of tumor will be collected and white blood cells will be separated to make the TIL for the treatment.
* Participants will take drugs to suppress the immune system for 7 days before the start of treatment.
* Participants will receive the TIL in a single dose. Then they will receive IL-2 every 8 hours for up to 15 doses. Participants will remain in the hospital for up to 2 weeks after treatment. They will be monitored with frequent blood tests and other studies.
* After leaving the hospital, participants will have regular followup visits every 1 to 4 months for the first year. Then they will return for followup every 3 to 4 months, as directed by the study researchers.

Conditions

Interventions

DRUG

Cyclophosphamide

60 mg/kg/day X 2 days intravenous (IV) over 1 hour on days -7 and -6

DRUG

Fludarabine

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

BIOLOGICAL

Aldesleukin

720,000 IU/kg intravenous (IV) over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)

BIOLOGICAL

Tumor Infiltrating Lymphocytes

Intravenous (IV) over 30 minutes on day 0

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-17
Primary Completion
2012-02-13
Completion
2012-02-14
FDA Drug
Yes

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 NCT01369875 on ClinicalTrials.gov