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.]

NCT02331693 : CAR T Cells in Treating Patients With Malignant Gliomas Overexpressing EGFR
PhasePhase 1
AgesMin: 18 Years Max: 70 Years
Eligibility
Inclusion Criteria:

1. Patients with histologically proven glioblastomas or gliosarcomas that overexpress
EGFR as assessed by IHC, FISH, western blot or RT-PCR.

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. Patients must be greater than or equal to 18 years of age and less than or equal to
age 70, and must have a life expectancy > 8 weeks

5. Patients must be able to understand and sign the Informed Consent Document

6. Must be willing to sign a durable power of attorney.

7. Patients of both genders must be willing to practice birth control for four months
following treatment.

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

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 unless antigen negative. 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.

10. 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 (eligibility level for
hemoglobin may be reached by transfusion)

11. Chemistry:

ALT/AST less than or equal to to 2.5 times the upper limit of normal Creatinine less
than or equal to to 1.6 mg/dl Total bilirubin less than or equal to 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. 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).

Exclusion Criteria:

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

2. Women who are currently pregnant or breast feeding because of the potentially
dangerous effects of the treatment on the fetus or infant.

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

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 to any of the agents including
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 an LVEF less than or equal to 45%.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02331693      |      Link to official Clinicaltrials.gov listing
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