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Sponsors and Collaborators: |
Roger Williams Medical Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00569296 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Biological: EGFRBi-armed autologous activated T cells Biological: aldesleukin Biological: sargramostim |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Anti-CD3 x Cetuximab-Armed Activated T Cells, Low Dose IL-2, and GM-CSF for EGFR-Positive, Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, Rhode Island | |
Roger Williams Medical Center | Recruiting |
Providence, Rhode Island, United States, 02908-4735 | |
Contact: Abby Maizel, MD, PhD 401-456-2698 |
Study Chair: | Abby Maizel, MD, PhD | Roger Williams Medical Center |
Study ID Numbers: | CDR0000577502, RWMC-RWH-07-349-32 |
Study First Received: | December 6, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00569296 History of Changes |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Anti-HIV Agents Cetuximab Antiviral Agents Recurrence Carcinoma Aldesleukin |
Respiratory Tract Diseases Anti-Retroviral Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Anti-Infective Agents Respiratory Tract Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Aldesleukin Anti-Retroviral Agents Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |