Status:
COMPLETED
Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Bankhead-Coley Florida Biomedical Research Program
James and Esther King Biomedical Research Program
Conditions:
Lung Cancer
Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the v...
Detailed Description
The vaccine will be made by mixing two kinds of cells: 1) some lung cancer cells, which have been grown in the lab, and 2) experimental "bystander (present but not taking part in the immune response)"...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic adenocarcinoma of the lung
- Patients must have received and completed first line therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- No external beam radiation therapy within 2 weeks of first vaccine administration
- No stereotactic radiation therapy within 3 days of first vaccine
- No targeted therapy within 2 weeks of first vaccine administration
- No immunomodulatory therapy within 2 weeks of first vaccine administration
- No chemotherapy within 4 weeks of first vaccine administration
- During Screening period, no steroid therapy within 4 weeks of first vaccine administration
- Patient's written informed consent
- Adequate organ function (measured within a week of beginning treatment):
- White blood count (WBC) \> 3,000/mm³ and absolute neutrophil count (ANC) \>/= 1500/mm³
- Platelets \> 100,000/mm³
- Hematocrit \> 25%
- Bilirubin \< 2.0 mg/dL
- Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min
- Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion.
- Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension.
Exclusion
- Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted.
- Any acute medical problems requiring active intervention
- Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
- Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus \[HIV\] infection)
- Any known pre-existing autoimmune disorder
- History of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ)
- Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment
- Pregnant or lactating women: Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment).
- Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
- Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study.
- Patients who at the discretion of the investigator are deemed to have rapidly progressive disease
Key Trial Info
Start Date :
March 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01433172
Start Date
March 26 2012
End Date
February 1 2019
Last Update
August 6 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612