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NCT Number: NCT01349647

Immunization With a Pentavalent Vaccine Composed of KLH-conjugates of GD2L, GD3L, Globo H, Fucosyl GM1, and N-Propionylated Polysialic Acid

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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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Confirm the safety of the pentavalent vaccine in this patient population

    Time frame: 1 year

    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.

  2. Confirm the immunogenicity of the pentavalent vaccine in this patient population

    Time frame: 1 year

    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.

Secondary outcomes

  1. To measure the B-cell response at the cellular level

    Time frame: 1 year

    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

  2. To evaluate the use of a circulating tumor cell (CTC) assay in this patient population.

    Time frame: 1 year

    with minimal residual disease to determine if levels correlate with recurrence.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 6, 2011
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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