Clinical trial NCT00654030: Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Official title: Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung Cancer Vaccine
Early Stage Lung Cancer
Lung Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Kentucky Lung Cancer Research Program
First posted: 2008-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells.

The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.

Detailed description: The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
* Surgically resected at least 4 weeks ago but not more than 6 months ago
* Bronchoalveolar carcinomas allowed
* Completion of any chemotherapy or radiation given in conjunction with Surgery (neoadjuvant or adjuvant)
* No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of enrollment
* ECOG performance status of 0 to 2
* Adequate organ and marrow function defined as follows:

  * Hemoglobin ≥9.0 gm/dL
  * Bilirubin \< 2.5 x upper limit of normal
  * AST \<2.5 x upper limit of normal
  * ALT \<2.5 x upper limit of normal
  * Creatinine \<3 mg/dL
* Women of childbearing potential must have a negative pregnancy test and be willing to use acceptable methods of contraception through week 16.

Exclusion Criteria:

* Cardiovascular disease defined as:

  * New York Heart Association Class III or IV (Section 19.2) congestive heart failure
  * hemodynamically significant valvular heart disease
  * myocardial infarction within the last six months
  * active angina pectoris
  * uncontrolled ventricular arrhythmias
  * stroke within one year
  * known cerebrovascular disease
* History of HIV, infectious hepatitis, or chronic immunosuppressive disease
* concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
* History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
* Female patients must not be pregnant or breastfeeding.
* History of participation in any investigational drug study within 4 weeks preceding initiation of study treatment.

Primary outcomes:
measure: Number of Participants Responding to the Vaccine
timeFrame: 16 weeks after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Commonwealth Cancer Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Medical Health System
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Edward A Hirschowitz, MD
role: STUDY_CHAIR
affiliation: University of Kentucky
name: John R Yannelli, PhD
role: STUDY_CHAIR
affiliation: University of Louisville
name: Goetz H Kloecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Commonwealth Cancer Center
name: Thomas R Baeker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Owensboro Medical Health System
name: Dattatraya S Prajapati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirschowitz EA, Foody T, Kryscio R, Dickson L, Sturgill J, Yannelli J. Autologous dendritic cell vaccines for non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2808-15. doi: 10.1200/JCO.2004.01.074.
citation: Hirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104.
citation: Hirschowitz EA, Mullins A, Prajapati D, Baeker T, Kloecker G, Foody T, Damron K, Love C, Yannelli JR. Pilot study of 1650-G: a simplified cellular vaccine for lung cancer. J Thorac Oncol. 2011 Jan;6(1):169-73. doi: 10.1097/JTO.0b013e3181fb5c22.