A Phase II Study of Lymphodepletion Followed by Autologous Tumor-Infiltrating Lymphocytes and High-Dose Aldesleukin for Human Papillomavirus-Associated Cancers

Inclusion Criteria

-INCLUSION CRITERIA:

1. Measurable metastatic or locally advanced refractory/recurrent malignancies that are
high-risk HPV positive by in situ hybridization (ISH) or polymerase chain reaction
(PCR) or any cancer from the uterine cervix.

2. All patients must have received prior platinum-based chemotherapy or
chemoradiotherapy.

3. Patients with 3 or less brain metastases are eligible. Note: If lesions are
symptomatic or greater than or equal to 1 cm each, these lesions must have been
treated and stable for 3 months for the patient to be eligible.

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

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:

- 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 be less responsive to
the experimental treatment and more susceptible to its toxicities.)

- 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.

- 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

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

- WBC greater than or equal to 3000/mm(3)

- Platelet count greater than or equal to 100,000/mm3

- Hemoglobin > 8.0 g/dl

11. Chemistry:

- Serum ALT/AST less than or equal to 2.5 times the upper limit of normal

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

- 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).

Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as
long as all toxicities have recovered to grade 1 or less.

EXCLUSION CRITERIA:

1. 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.

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

3. 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).

4. Concurrent systemic steroid therapy.

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

6. History of coronary revascularization or ischemic symptoms.

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

8. Documented LVEF of less than or equal to 45% tested in patients with i) clinically
significant atrial and/or ventricular arrhythmias including but not limited to:
atrial fibrillation, ventricular tachycardia, second or third degree heart block or
ii) age greater than or equal 60 years old.

9. Documented FEV1 less than or equal to 60% of predicted tested in patients with i) a
prolonged history of cigarette smoking or ii) symptoms of respiratory dysfunction.