Status:
TERMINATED
CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Metastatic Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients metastatic cancer that involves taking white blood cells from the patient, g...
Detailed Description
Background: * We have constructed a single retroviral vector that contains a chimeric T cell receptor (CAR) that recognizes the Vascular Endothelial Growth Factor Receptor 2 (VEGFR2), which can be us...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Metastatic cancer with evaluable disease.
- Patients must have previously received at least one systemic standard care (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 recurred.
- Greater than or equal to 18 years of age and less than or equal to 70 years of age.
- Willing to sign a durable power of attorney
- Able to understand and sign the Informed Consent Document
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Life expectancy of greater than three months.
- 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 treatment.
- Serology:
- Seronegative for human immunodeficiency virus (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 reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative.
- Hematology:
- Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim.
- White blood cell (WBC) (\> 3000/mm(3)).
- Platelet count greater than 100,000/mm(3).
- Hemoglobin greater than 8.0 g/dl.
- Chemistry:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less 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 Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- 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).
- More than 4 weeks must have elapsed since an surgical procedure at the time the patient receives the preparative regimen due to the inhibition of wound healing observed with vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors.
- EXCLUSION CRITERIA:
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- Patients with known brain metastases.
- Patients receiving full dose anticoagulative therapy.
- Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- 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).
- Patients with diabetic retinopathy.
- Concurrent Systemic steroid therapy.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- History of coronary revascularization or ischemic symptoms.
- In patients
- Documented forced expiratory volume 1 (FEV1) less than or equal to 45% predicted tested in patients with:
- History of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
- Age greater than or equal to 60 years old.
Exclusion
Key Trial Info
Start Date :
November 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01218867
Start Date
November 10 2010
End Date
December 15 2015
Last Update
December 10 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892