Non-Small Cell Lung Cancer
Conditions
Keywords
Lung Cancer Vaccine, Early Stage Lung Cancer, Lung Cancer
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.
Interventions
DRUG1650-G Vaccine
.6ml injection administered intradermally in the thigh at week 0 and week 4
Sponsors
Kentucky Lung Cancer Research Program
Edward Hirschowitz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Responding to the Vaccine | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1650-G Arm Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | 1650-G Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 11.21 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 4 / 12 |
Outcome results
Primary
Number of Participants Responding to the Vaccine
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.
Time frame: 16 weeks after vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1650-G ARM | Number of Participants Responding to the Vaccine | 6 Participants |