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|NCT01454596 : CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: 70 Years|
1. Patients with histologically proven glioblastomas or gliosarcomas that express
EGFRvIII as assessed by IHC or PCR confirmed by Laboratory of Pathology, NCI.
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
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 > 18 years old and less than or equal to age 70
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 must have a Karnofsky performance status of greater than or equal to 60
8. Patients of both genders must be willing to practice birth control for four months
9. Women of child bearing potential must have a negative pregnancy test because of the
potentially dangerous effects of the treatment on the fetus.
- 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.
- 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)
- 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.
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
14. Subject s must be co-enrolled in protocol 03-C-0277
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, (e.g.: requiring anti-infective treatment) coagulation
disorders or any other major medical illnesses
4. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
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%.
11. Documented FEV1 less than or equal to 60% predicted tested in patients with:
- A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2
- Symptoms of respiratory dysfunction
12. Patients who are receiving any other investigational agents.
13. Documented LVEF of less than or equal to 45% tested in patients with:
- Clinically significant atrial and/or ventricular arrhythmias including but not
limited to: atrial fibrillation, ventricular tachycardia, second or third degree
heart block, chest pain, or ischemic heart disease
Age greater than or equal to 65 years old
|Links||Permanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01454596
| Link to official Clinicaltrials.gov listing
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center Phone: 866-820-4505
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