Clinical trial NCT01349647: Immunization With a Pentavalent Vaccine Composed of KLH-conjugates of GD2L, GD3L, Globo H, Fucosyl GM1, and N-Propionylated Polysialic Acid
Official title: Immunization of Small Cell Lung Cancer Patients With a Pentavalent Vaccine Composed of KLH-conjugates of GD2L, GD3L, Globo H, Fucosyl GM1, and N-Propionylated Polysialic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: FUCOSYL-GM1-KLH
GLOBO H-KLH CONJUGATE
OPT-821
POLYSIALIC ACID - KLH
Vaccine
08-095
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Even when small cell lung cancer responds well to treatment with chemotherapy, it has a tendency to grow back and to spread. The investigators are interested in testing new therapies aimed at decreasing this risk. This study tests a vaccine, which is a substance injected under the skin which can cause an immune response. The hope is that the body will make antibodies to the vaccine which will also react against the cancer. The vaccine is specific for small cell lung cancer. It combines several components (small cell lung cancer targets) that have been tested individually in patients with small cell lung cancer or other cancers (GD2, GD3, Globo H, Fucosyl GM1 and N-propionylated polysialic acid). Two other substances (KLH and OPT-821) are added which boost the immune system.

This study will have two groups of patients. The first group will receive the vaccines along with one cycle of chemotherapy. The second group will receive the vaccines without chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients must have small cell lung cancer confirmed by the Department of Pathology at Memorial Sloan-Kettering Cancer Center.
* Patients may have limited or extensive stage disease at the time of diagnosis.
* Patients must have completed first-line therapy, with or without thoracic and/or cranial irradiation, and have achieved either a complete response or partial response to therapy without subsequent evidence of disease progression.
* At least 3 weeks must have elapsed between the time the patient completed chemotherapy and the first vaccination.
* No more than 8 weeks can elapse between the time the patient completed chemotherapy and the first vaccination.
* If the patient received thoracic or cranial irradiation after completing the chemotherapy, at least 1 week must have elapsed after the radiation before the first vaccination. Patients must have recovered from the acute toxicities of the radiation prior to starting the vaccine therapy.
* Karnofsky Performance Status \> or = to 70%.
* Hematologic parameters:
* WBC \> or = to 3.0 x 10\^3 cells/µl
* Total lymphocyte count \> or = to 0.5 x 10\^3 cells/µl
* Platelet count \> 100,000/µl
* Biochemical parameters
* Creatinine clearance \> or = to 40 ml/min
* Total bilirubin \< or = to 1.5 x upper limits of normal
* AST and ALT \< or = to 2.5 x upper limits of normal
* Patients must be able to give written informed consent.
* Patients must be ≥ 18 years old.

Exclusion Criteria:

* Patients with progression of disease after first-line chemotherapy.
* Pregnant or lactating women.
* Patients with a history of immunodeficiency or autoimmune disease, or who have undergone radiation to the spleen or splenectomy.
* Patients with a history of leptomeningeal disease.
* Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
* Patients with serious unstable medical illness.
* Patients taking systemic corticosteroids.
* Patients with peripheral sensory neuropathy \> grade 1.
* Patients who have used non-steroidal anti-inflammatory medications within 2 weeks of vaccination.

Primary outcomes:
measure: Confirm the safety of the pentavalent vaccine in this patient population
timeFrame: 1 year
measure: Confirm the immunogenicity of the pentavalent vaccine in this patient population
timeFrame: 1 year
Secondary outcomes:
measure: To measure the B-cell response at the cellular level
timeFrame: 1 year
measure: To evaluate the use of a circulating tumor cell (CTC) assay in this patient population.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Krug, MD
role: PRINCIPAL_INVESTIGATOR
References: