Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer

Completed · Phase 1/Phase 2

Conditions studied: Lung Cancer, Adenocarcinoma

In brief

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 vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.

Key facts

Study ID

NCT01433172

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

73

Starts

2012-03-26

Expected to finish

2019-02-01

Last updated by the study team

2019-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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