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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant
Biological/Vaccine: vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring FUCOSYL-GM1-KLH, GLOBO H-KLH CONJUGATE, OPT-821, POLYSIALIC ACID - KLH, Vaccine, 08-095

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vaccine and Chemotherapy

Vaccine Alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
To evaluate the use of a circulating tumor cell (CTC) assay in this patient population.
with minimal residual disease to determine if levels correlate with recurrence.

Full Information

First Posted
May 5, 2011
Last Updated
January 4, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01349647
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
FUCOSYL-GM1-KLH, GLOBO H-KLH CONJUGATE, OPT-821, POLYSIALIC ACID - KLH, Vaccine, 08-095

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine and Chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaccine Alone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Biological/Vaccine: vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant
Intervention Description
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 Outcome Measure Information:
Title
Confirm the safety of the pentavalent vaccine in this patient population
Description
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.
Time Frame
1 year
Title
Confirm the immunogenicity of the pentavalent vaccine in this patient population
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To measure the B-cell response at the cellular level
Description
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
Time Frame
1 year
Title
To evaluate the use of a circulating tumor cell (CTC) assay in this patient population.
Description
with minimal residual disease to determine if levels correlate with recurrence.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Krug, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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