Phase 2
Completed N=12
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00654030 ↗Enrolled (actual)
12
Serious AEs
33.3%
Results posted
May 2013
Primary outcomePrimary: Number of Participants Responding to the Vaccine — 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Responding to the Vaccine |
6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00654030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.