Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung 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 2

Primary location

Commonwealth Cancer Center, Danville, Kentucky, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

1650-G Vaccine

Drug

.6ml injection administered intradermally in the thigh at week 0 and week 4

Other names: 1650-G Allogeneic Cellular Vaccine

Primary outcomes

Number of Participants Responding to the Vaccine

Time frame: 16 weeks after vaccination

The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.

Sponsors and collaborators

Lead sponsor

Edward Hirschowitz

Other

Collaborators

Kentucky Lung Cancer Research Program

Registry information

Official study title

Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Apr 7, 2008
Registry last updated: Apr 9, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed