Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-mesothelin Gene Engineered Lymphocytes

Inclusion Criteria

- INCLUSION CRITERIA:

1. Metastatic or unresectable measurable cancers that express mesothelin.
Epithelial mesotheliomas and pancreatic cancers do not need to be assessed for
mesothelin expression since all of these tumors have been shown to express
mesothelin.

2. Patients must have previously received at least one systemic standard care (or
effective salvage chemotherapy regimens) for metastatic or unresectable disease,
if known to be effective for that disease, and have been either non-responders
(progressive disease) or have recurred.

3. Greater than or equal to 18 years of age.

4. Willing to sign a durable power of attorney

5. Able to understand and sign the Informed Consent Document

6. Clinical performance status of ECOG 0 or 1.

7. Life expectancy of greater than three months.

8. Patients of both genders must be willing to practice birth control from the time
of enrollment on this study and for up to four months after receiving the
preparative regimen.

9. Serology:

1. 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 immunecompetence and thus be less
responsive to the experimental treatment and more susceptible to its
toxicities.)

2. Seronegative for hepatitis B antigen, 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.

3. Women of child-bearing potential must have a negative pregnancy test
because of the potentially dangerous effects of the preparative
chemotherapy on the fetus.

10. Hematology:

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

2. WBC (> 3000/mm(3)).

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

4. Hemoglobin greater than 8.0 g/dl.

11. Chemistry:

1. Serum ALT/AST less or equal to 2.5 times the upper limit of normal.

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

3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with
Gilbert's Syndrome who must have a total bilirubin less than 3.0 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 (except for toxicities such as alopecia or
vitiligo).

EXCLUSION CRITERIA:

1. Patients with sarcomatoid mesothelioma as mesothelin is not expressed in this type of
mesothelioma.

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

3. Patients with known brain metastases.

4. Patients receiving full dose anticoagulative therapy.

5. Active systemic infections, coagulation disorders or other major medical illnesses of
the cardiovascular, respiratory or immune system, myocardial infarction, cardiac
arrhythmias, obstructive or restrictive pulmonary disease.

6. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
Disease).

7. 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).

8. Patients with diabetic retinopathy.

9. Concurrent Systemic steroid therapy.

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

11. History of coronary revascularization or ischemic symptoms.

12. Documented FEV1 less than or equal to 60% predicted tested in all patients.

13. In patients over 60 years of age, LVEF of less than 45%