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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine and Chemotherapy | Experimental | This is a pilot trial evaluating the safety and immunogenicity of a pentavalent vaccine for patients with small cell lung cancer (SCLC). Patients with SCLC who have completed all planned initial therapy and have maintained a partial or complete response will be enrolled. |
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| Vaccine Alone | Experimental | Patients will be vaccinated with the pentavalent vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant | Biological | Patients will be vaccinated with the pentavalent vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant. Patients will receive vaccine at weeks 1, 2, 3, 9, 20, and 32. Patients will also receive one cycle of chemotherapy with etoposide and cisplatin or carboplatin at week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm the safety of the pentavalent vaccine in this patient population | After immunization with a pentavalent vaccine, including KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid, with the adjuvant OPT-821. Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The vaccination will be considered safe if no more than 1 patient has new grade 2 neurotoxicity, grade 3 hepatotoxicity, new autoimmunity or grade 4 local or grade 3 systemic toxicity requiring cessation of treatment. | 1 year |
| Confirm the immunogenicity of the pentavalent vaccine in this patient population | an antibody titer of > or = to 1:80 by ELISA against a given antigen or an ELISA titer > or = to 8 fold increase over baseline for patients with a detectable baseline titer; ) confirmation by FACS against tumor cells expressing the four antigens. An increase in percent positive cells by FACS by 3-fold (over 30%) compared to pretreatment level, with the pretreatment level set at 10%, is a positive FACS response. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the B-cell response at the cellular level | by generating and analyzing monoclonal antibodies against GD2L, GD3L, Globo H, Fucosyl GM1, and NPropionylated Polysialic Acid and to compare the avidity of the induced antigen specific IgG and IgM antibodies which is not possible with sera | 1 year |
| To evaluate the use of a circulating tumor cell (CTC) assay in this patient population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Krug, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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|
| Biological/Vaccine: vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant | Biological | Patients will be vaccinated with the pentavalent vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant. Patients will receive vaccine at weeks 1, 2, 3, 4, 8, and 16. |
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with minimal residual disease to determine if levels correlate with recurrence. |
| 1 year |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C472765 | Globo-H |
| C039123 | fucosyl GM1 ganglioside |
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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