Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01454596 : CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: 70 Years
Eligibility
-INCLUSION CRITERIA:

1. Patients with histologically proven glioblastomas or gliosarcomas that express
EGFRvIII as assessed by IHC or PCR confirmed by the NCI Laboratory of Pathology.

2. Patients must have progression of disease after radiotherapy (including patients that
undergo surgery for recurrent disease and are rendered NED). This includes recurrent
GBM after receiving all standard first-line treatment, including surgery (if feasible
due to neurosurgical and neuro-anatomical considerations) and adjuvant radiotherapy
+/- chemotherapy.

3. Patients must either not be receiving steroids, or be on a stable dose of steroids for
at least five days prior to registration.

4. Age greater than or equal to 18 years and less than or equal to age 70 years.

5. Ability of subject to understand and the willingness to sign a written informed
consent document.

6. Willing to sign a durable power of attorney.

7. KPS greater than or equal to 60

8. 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.

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

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 may 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 patients must be tested for the
presence of antigen by RT-PCR and be HCV RNA negative.

11. Hematology

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

- ANC greater than or equal to 1000/mm(3) without the support of filgrastim

- Platelet count greater than or equal to 100,000/mm(3)

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

12. Chemistry

- Serum ALT/AST less than or equal to 2.5 x ULN

- 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 equal to or less than 3.0 mg/dl.

13. Patients must be at least 4 weeks from radiation therapy. Additionally, patients must
be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide, 3 weeks from
procarbazine, 2 weeks from vincristine and 4 weeks from last bevacizumab
administration. Patients must be at least 4 weeks from other cytotoxic therapies not
listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen)
including investigative agents. All toxicities from prior therapies should be resolved
to CTCAE less than or equal to grade 1 (except for toxicities such as alopecia, or
vitiligo).

14. Subject s must be co-enrolled on protocol 03-C-0277

EXCLUSION CRITERIA:

1. A prior history of gliadel implantation in the past six months..

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

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

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

5. 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).

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

7. History of coronary revascularization or ischemic symptoms.

8. Clinically significant hemorrhagic or ischemic stroke, including transient ischemic
attacks and other central nervous system bleeding in the preceding 6 months that were
not related to glioma surgery. History of prior intratumoral bleeding is not an
exclusion criteria; patients who with history of prior intratumoral bleeding, however,
need to undergo a non-contrast head CT to exclude acute bleeding.

9. Other concomitant anti-cancer therapy except corticosteroids.

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

11. 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

12. Patients who are receiving any other investigational agents.

13. 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 pain.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01454596      |      Link to official Clinicaltrials.gov listing
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