Status:
ACTIVE_NOT_RECRUITING
Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Sarcoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients have a type of cancer called sarcoma. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, pati...
Detailed Description
Because the cells have a new gene in them the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer. When the patient is enrolled on this st...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Procurement Eligibility:
- Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive osteosarcoma.
- Karnofsky/Lansky score of 50 or greater
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Treatment Eligibility:
- Diagnosis of refractory HER2-positive sarcoma or metastatic HER2-positive sarcoma with disease progression after receiving at least one prior systemic therapy.
- Recovered from acute toxic effects of all prior cytotoxic chemotherapy at least 4 weeks before entering this study. PD1/PDL1 inhibitors will be allowed to continue during treatment if medically indicated.
- Normal ECHO (Left ventricular ejection fraction (LVEF) has to be within normal, institutional limits)
- Life expectancy 6 weeks or greater
- Karnofsky/Lansky score of 50 or greater
- Bilirubin 3x or less, AST 3x or less, Serum creatinine 2x upper limit of normal or less, Hgb 7.0 g/dl or greater, WBC greater than 2,000/ul, ANC greater than 1,000/ul, platelets greater than 100,000/ul. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal.
- Pulse oximetry of 90% or greater on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom
- Available autologous transduced T lymphocytes with 15% or more expression of HER2 CAR as determined by flow-cytometry and killing of HER2-positive targets 20 % or greater in cytotoxicity assay.
- Chest radiograph for baseline evaluation of lungs
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
- EXCLUSION CRITERIA:
- At time of Procurement:
- Known HIV positivity
- Severe previous toxicity from cyclophosphamide or fludarabine
- At time of Treatment:
- Severe intercurrent infection
- Known HIV positivity
- Pregnant or lactating
- History of hypersensitivity reactions to murine protein-containing products
- Severe previous toxicity from cyclophosphamide or fludarabine
Exclusion
Key Trial Info
Start Date :
February 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00902044
Start Date
February 11 2010
End Date
July 1 2032
Last Update
December 27 2024
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030