Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients with Metastatic Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01174121

Provider View

This study is testing a new treatment that uses a patient's own immune cells, taken from their tumors, to fight cancer. The treatment aims to see if these cells can shrink tumors in patients with certain types of cancer and if it is safe to use.

Patient Parameters

Program Overview

Researchers are exploring a new treatment for metastatic cancer that involves using a patient's own white blood cells, called Tumor Infiltrating Lymphocytes (TIL), to attack cancer cells. These cells are taken from the patient's tumor, grown in large numbers in a lab, and then given back to the patient. The study focuses on cancers of the digestive tract, urinary system, breast, and ovaries or uterus. The goal is to see if this treatment can shrink tumors and is safe for patients.

Description

This clinical trial is investigating a new approach to treating metastatic cancer by using Tumor Infiltrating Lymphocytes (TIL). These are special white blood cells taken from a patient's tumor, grown in the lab, and then reintroduced into the patient's body to help fight the cancer. The study is focused on patients with cancers of the digestive tract, urinary system, breast, ovaries, or uterus that have not responded to standard treatments.

The process begins with a thorough medical evaluation, including scans and tests, to ensure patients meet the study criteria. If eligible, patients will undergo surgery to remove a tumor sample, which will be used to grow the TIL cells. Some patients may also have a procedure called leukapheresis to collect additional white blood cells.

Once the TIL cells are ready, patients will be admitted to the hospital to receive chemotherapy to prepare their body, followed by the TIL cells and a medication called aldesleukin. This hospital stay will last about four weeks.

After treatment, patients will have regular follow-up visits to monitor their health and the treatment's effects. These visits will include physical exams, lab tests, and scans, occurring every 1-3 months in the first year and then every 6-12 months as long as the tumors are shrinking.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18-72 with metastatic cancer in the digestive tract, liver, urinary system, breast, ovaries, uterus, or certain brain tumors.
  • Cancer must not have responded to standard chemotherapy.
  • Must have at least one tumor that can be safely removed for TIL production.
  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Must agree to use birth control during the study and for 12 months after treatment for women, and for four months for men.
  • Women must not be pregnant and must undergo a pregnancy test before starting treatment.
  • Must test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Must have adequate blood cell counts and organ function as indicated by specific tests.
  • Must have completed any previous cancer treatments and recovered from any side effects.
  • Must understand the study and agree to sign informed consent.
  • Must be willing to sign a durable power of attorney.
  • Must be enrolled in a related study protocol (03-C-0277).

Exclusion Criteria

  • Women who are pregnant or breastfeeding due to potential risks to the baby.
  • Currently taking systemic steroids or other immunosuppressive medications.
  • Have active infections requiring treatment or other serious medical conditions.
  • Have severe liver problems due to cancer spread.
  • Have blockages or bleeding in the digestive tract that are not managed.
  • Have any form of primary immunodeficiency.
  • Have a history of severe allergic reactions to any of the study drugs.
  • Have had recent heart procedures or symptoms of heart disease.
  • Have significant lung problems, such as very low lung function.
  • Have a history of severe autoimmune diseases affecting major organs.
  • Are currently participating in another clinical trial or taking investigational drugs.

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