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
18 Years
N/A
Both
Lung Cancer
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 Center | New York, New York 10021 |
