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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirm the safety of the pentavalent vaccine in this patient population

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Lee Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

08-095

NCT ID:

NCT01349647

Start Date:

May 2011

Completion Date:

May 2014

Related Keywords:

  • Lung Cancer
  • FUCOSYL-GM1-KLH
  • GLOBO H-KLH CONJUGATE
  • OPT-821
  • POLYSIALIC ACID - KLH
  • Vaccine
  • 08-095
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021