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Biliary Tract Cancers - Healing Genes
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Biliary Tract Cancers

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Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers


Phase 2

DESCRIPTION:

Doctors at the University of Pittsburgh Medical Center Hillman Cancer Center are recruiting patients with locally advanced, recurrent, or metastatic biliary tract cancers to trial a therapy of certain immune cells, or lymphocytes, that tend to infiltrate tumors(tumor-infiltrating lymphocytes, or TILs). These TILs will be extracted from the patient, cultured and returned to fight the tumor in higher numbers.

This investigatory treatment aims to assure the safety of the treatment in combination with chemotherapy and a drug approved for increasing production of the TILs and other tumor-fighting immune cells.


PATIENT MUST:

  • Be 18 to 75 years of age
  • Have measurable locally advanced, recurrent, or metastatic biliary tract carcinoma (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
  • Meet criteria for any prior treatments or surgical operability (typically that both are not successful)
  • Be HIV-negative
  • Be willing to use contraception and not be pregnant

THE STUDY INVOLVES:

  1. Prescreening at the study site to confirm eligibility of the patient to participate.
  2. Apheresis, or collection of the patient’s blood stem cells, will be conducted at the study site.
  3. Chemotherapy treatment will reduce the patient’s bone marrow.
  4. One-time Infusion of the investigational drug made from the patient’s cells over 24 hours, with observation period, and every-8-hours infusions (6 total) of the drug to promote TIL growth.
  5. Follow up at the study site location at a regular schedule for up to 24 months.

LOCATIONS AND CONTACTS:

The study will take place at the UPMC Hillman Cancer Center. Map.

Contacts:

Samantha Perkins,, PA-C  |  412-623-5960  |  [email protected]

Krystle L Eaton, BSN  |  412-623-7957  |  [email protected]

 

SPONSOR INFORMATION:

Udai Kammula

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03801083

 

 

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