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A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung

Phase 1/Phase 2
18 Years
Open (Enrolling)
Lung Cancer, Adenocarcinoma

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Trial Information

A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung

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)" cells. All the cells in the vaccine will be treated with high-dose X-rays
to make sure that none of them grow and cause more cancer. The bystander cells are human
cells that have been genetically changed to express GM-CSF and CD40L. These are called
"GM.CD40L". (That is the original cells, called K562, with the genes for human GM-CSF and
CD40L inserted into them). These changes are designed to help boost the participants immune
system to better fight the cancer in their body. GM-CSF is a hormone that is known to
stimulate bone marrow to make more white blood cells.

CCL21 is a chemokine (protein) that helps to recruit T cells (a type of white blood cell
that helps to protect the body from infections) and leads to hyper-responsive T cells. This
leads to heightened immune responses when T cells are exposed to both CCL21 and antigen (a
substance that when introduced into the body lead to production of an antibody)-presenting
cells (A cell that can "present" antigen in a form that T cells can recognize it ). The
induction of a strong cell-mediated immune response is the type of immunity expected to be
most involved in controlling cancer cell growth. A randomized trial of a vaccine consisting
of the GM.CD40L bystander cells and an equivalent number of allogeneic (taken from different
individuals) tumor cells plus or minus CCL21 is proposed.

Inclusion Criteria:

- 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

- 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) >/=

- 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 Criteria:

- 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).

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Progressive Free Survival (PFS)

Outcome Description:

Once the maximum tolerated dose (MTD) is established in the phase I, additional patients will be enrolled at this dose level to a total of 64 on a randomized phase II trial (32 per each arm). The primary endpoint for the trial will be 6-month progression free survival (PFS).

Outcome Time Frame:

6 Months

Safety Issue:


Principal Investigator

Jhanelle Gray, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

April 2015

Related Keywords:

  • Lung Cancer
  • Adenocarcinoma
  • stage IV
  • adenocarcinoma
  • vaccine therapy
  • immunology
  • tumor vaccine
  • colony stimulating factor(CSF)
  • granulocyte-macrophage colony-stimulating factor (GM-CSF)
  • CC chemokine ligand 21 (CCL21)
  • Chemokine [C-C motif] ligand 21 (CCL21)
  • human leukocyte antigen serotype (HLA)
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612