Clinical Trial Details
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NCT01174121 : Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
PhasePhase 2
AgesMin: 18 Years Max: 70 Years

1. Measurable metastatic (stage IV) gastric, gastroesophageal, pancreatic, hepatocellular
carcinoma, cholangiocarcinoma, gallbladder, colorectal, urothelial, breast,
ovarian/endometrial carcinoma, or glioblastoma with at least one lesion that is
resectable for TIL generation with minimal morbidity preferentially using minimal
invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor
deposit, plus one other lesion that can be measured.

2. All patients must be refractory to approved standard systemic therapy.

Specifically :

- Metastatic colorectal patients must have received oxaliplatin or irinotecan.

- Hepatocellular carcinoma patients must have received sorafenib (Nexavar ), since
level 1 data support a survival benefit with this agent.

- Breast and Ovarian cancer patients must be refractory to both 1st line and 2nd
line treatments and must have received at least one second line chemotherapy

- Patients with recurrent glioblastoma that have received standard surgery,
radiation therapy, and chemotherapy for their primary tumors and require
resection of their tumors for palliative or other clinical indications. These
patients will not undergo surgery solely for treatment on this protocol.

3. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and
asymptomatic are eligible. Lesions that have been treated with stereotactic
radiosurgery must be clinically stable for 1 month after treatment for the patient to
be eligible.

4. Clinical performance status of ECOG 0 or 1.

5. Greater than or equal to 18 years of age and less than or equal to 70 years of age.

6. Willing to practice birth control during treatment and for four months after receiving
the treatment.

7. Willing to sign a durable power of attorney.

8. Able to understand and sign the Informed Consent Document.

9. Hematology:

- Absolute neutrophil count greater than 1000/mm(3) without support of filgrastim.

- Normal WBC (> 3000/mm(3)).

- Hemoglobin greater than 8.0 g/dl. Subjects may be transfused to reach this

- Platelet count greater than 100,000/mm(3).

- Normal prothrombin time (less than or equal to 15.2 seconds).

10. Serology:

- Seronegative for HIV antibody. (The experimental treatment being evaluated in
this protocol depends on an intact immune system. Patients who are HIV
seropositive can have decreased immune competence and thus may be less responsive
to the experimental treatment and more susceptible to its toxicities.)

- Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
If hepatitis C antibody test is positive, then patient must be tested for the
presence of antigen by RT-PCR and be HCV RNA negative.

11. Chemistry:

- Serum ALT/AST less than five times the upper limit of normal.

- Serum creatinine less than or equal to 1.6 mg/dl.

- Total bilirubin less than or equal to 2 mg/dl, except in patients with Gilbert's
Syndrome, who must have a total bilirubin less than or equal to 3 mg/dl.

12. More than four weeks must have elapsed since any prior systemic therapy at the time
the patient receives the preparative regimen, and patients' toxicities must have
recovered to a grade 1 or less. Patients may have undergone minor surgical procedures
with the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.

13. Four weeks must have elapsed since any prior antibody therapies to allow antibody
levels to decline.

14. Subjects must be co-enrolled in protocol 03-C-0277.


1. Women of child-bearing potential who are pregnant or breastfeeding because of the
potentially dangerous effects of the treatment on the fetus or infant.

2. Concurrent systemic steroid therapy. (Note: Patients with recurrent glioblastoma who
require steroids for clinical indications are eligible.)

3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation
disorders or any other active major medical illnesses

4. Advanced primary with impeding occlusion, perforation or bleeding, dependant on

5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease
and AIDS).

6. History of major organ autoimmune disease.

7. Grade 3 or 4 major organ Immune-Related Adverse Events (IRAEs) following treatment
with anti-PD-1/PD-L1

8. Concurrent opportunistic infections (The experimental treatment being evaluated in
this protocol depends on an intact immune system. Patients who have decreased immune
competence may be less responsive to the experimental treatment and more susceptible
to its toxicities.)

9. History of severe immediate hypersensitivity reaction to any of the agents used in
this study.

10. History of coronary revascularization or ischemic symptoms.

11. Any patient known to have an LVEF less than or equal to 45%.

12. Documented LVEF of less than or equal to 45% tested in patients with:

- Clinically significant atrial and/or ventricular arrhythmias including but not
limited to: atrial fibrillation, ventricular tachycardia, second or third degree
heart block

- Age greater than or equal to 60 years old

13. Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known
underlying liver dysfunction.

14. Documented FEV1 less than or equal to 60% predicted tested in patients with:

- A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2

- Symptoms of respiratory dysfunction

15. Patients who are receiving any other investigational agents.
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