Clinical Trial Details
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NCT01967823 : T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer
PhasePhase 2
AgesMin: 15 Years Max: 70 Years

- Measurable (per RECIST v1.0 criteria) metastatic cancer or locally advanced
refractory/recurrent malignancy including melanoma that expresses ESO as assessed by
one of the following methods: RT-PCR on tumor tissue, immunohistochemistry of resected
tissue, or serum antibody reactive with ESO.

- Confirmation of diagnosis of metastatic cancer including melanoma by the NCI
Laboratory of Pathology.

- Patients must have previously received first-line standard therapy (or effective
salvage chemotherapy regimens) for metastatic disease, if known to be effective for
that disease, and have been either non-responders (progressive disease) or have

- 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.Patients with surgically resected brain metastases are eligible.

- 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 three weeks, as
long as all toxicities have recovered to grade 1 or less.

Note: Patients who have previously received ipilimumab and have documented GI toxicity must
have a normal colonoscopy with normal colonic biopsies.


- Histologically proven recurrent meningioma or aggressive meningioma.

Note: Confirmation of ESO expression and pathology is not required in patients with
definitive radiologic evidence of meningioma who are unresectable, and in whom radiation
therapy without biopsy is the standard treatment.

- Recurrent disease/progression after receiving all standard treatments, which must
include the following:

- Surgical resection, if possible.

- Definitive radiation therapy for unresectable meningioma, or for recurrent
meningioma after resection.

- At least 4 weeks post-surgery, and must be at least 3 months post-radiation therapy,
with resolution of related toxicities.

- Measurable disease on MRI scan.

- No history of intracranial hemorrhage.

- Patients with a history of neurofibromatosis (NF) may have other stable CNS tumors,
such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been
stable for the past 6 months.

- Patients must be on stable dose of steroids for at least 5 days prior to baseline


- Age greater than or equal to 15 years and less than or equal to 70 years..

- Patient, or their parent(s)/legal guardian(s) (if the patient is < 18 years of age),
is able to understand and willing to sign a written informed consent. Written assent
will be obtained for participants under the age of 18 as appropriate.

- All participants greater than or equal to 18 years of age must be willing to sign a
durable power of attorney.

- Clinical performance status of ECOG 0 or 1.

- Patients aged 15-17 years weigh greater than or equal to 50 kg.

- HLA-A*0201 positive.

- Patients of both genders must be willing to practice birth control from the time of
enrollment on this study and for four months after treatment.

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

- Serology

- Seronegative for HIV antibody. (The experimental treatment being evaluated in
this protocol depends on an intact immune system. Patients who are HIV
seropositive may have decreased immune-competence and thus may 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.

- Hematology

- ANC 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/mm(3)

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

- 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.

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


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

- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency

- Active systemic infections requiring anti-infective treatment, coagulation disorders,
or any other active or uncompensated major medical illnesses.

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

- Concurrent systemic steroid therapy.

- History of severe immediate hypersensitivity reaction to cyclophosphamide,
fludarabine, or aldesleukin.

- History of coronary revascularization or ischemic symptoms.

- Documented LVEF less than or equal to 45% tested in patients:

- Age greater than or equal to 65 years

- With clinically significant atrial and/or ventricular arrhythmias, including but
not limited to: atrial fibrillation, ventricular tachycardia, second- or
third-degree heart block or have a history of ischemic heart disease and/or chest

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

- A prolonged history of cigarette smoking (greater than or equal to 20 pack-year
smoking history, with cessation within the past two years).

- Symptoms of respiratory dysfunction.

- Patients who are receiving any other investigational agents.
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