A Phase 1 interventional study of EGFRBi-armed autologous activated T cells and aldesleukin in Lung Cancer, sponsored by Roger Williams Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Roger Williams Medical Center · Phase 1, Interventional, and Treatment
RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic non-small cell lung cancer.
FUNDING SOURCE--FDA OOPD
OBJECTIVES:
Primary
Secondary
OUTLINE: Peripheral blood mononuclear cells (PBMCs) are collected by 1 or 2 leukaphereses for the generation of activated T cells (ATCs). The PBMCs are activated with OKT3 (anti-CD3) and expanded in aldesleukin for up to 14 days. The ATCs are then armed with EGFRBi.
Patients receive EGFRBi-armed autologous ATCs IV over 30-60 minutes twice weekly for 4 weeks (a total of 8 infusions) in the absence of disease progression or unacceptable toxicity. Patients also receive low-dose aldesleukin subcutaneously (SC) once daily and sargramostim (GM-CSF) SC twice weekly beginning 3 days before the first ATC infusion and continuing for 1 week after the last ATC infusion.
After completion of study therapy, patients are followed periodically.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Roger Williams Medical Center is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
No clinical evidence of active brain metastases
PATIENT CHARACTERISTICS:
LVEF ≥ 45 % at rest (by MUGA)
No other malignancy, except for the following:
No systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg
PRIOR CONCURRENT THERAPY:
EGFRBi-armed autologous activated T cells
Biological: EGFRBi-armed autologous activated T cells · Biological: aldesleukin · Biological: sargramostim
Dose escalation, dosage depends on when entered in study. 8 infusions (twice a week over 4 weeks. Each infusion will be over at least 1 hour.
300,00IU/m2/day beginning 3 days before the first Activated T-cell infusion and ending 1 week after the last infusion
Also known as: IL-2
250 micrograms/m2/twice weekly beginning 3 days before the first activated T-cell infusion and ending 1 week after the last Activated T-cell infusion
Also known as: GM-CSF
Safety
Time frame: 4 weeks
Maximum tolerated dose of EGFRBi-armed autologous activated T-cells
Time frame: 4 weeks
Determination of immunologic changes by evaluation of cytokine profiles obtained before and after stimulation with OKT3 in vitro
Time frame: 4 weeks
Overall survival
Time frame: 2 years
Progression-free survival
Time frame: 2 years
Evaluation of tumor markers and human anti-mouse antibody responses as assessed by carcinoembryonic antigen (CEA) levels in serum samples and development of IgG and IgM anti-mouse antibody responses to the Bi-antibodies
Time frame: 4 weeks
Determination of immunologic changes by evaluation of peripheral blood lymphocytes
Time frame: 4 weeks
Determination of immunologic changes by evaluation of cytotoxic T-lymphocytes as measured by interferon gamma ELISPOTS directed at autologous tumor or lung cancer cell lines
Time frame: 4 weeks
Determination of immunologic changes by evaluation of phenotypes of peripheral blood mononuclear cells before and after immunotherapy
Time frame: 4 weeks
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Roger Williams Medical Center