Phase 2 N=12 Treatment

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

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00654030 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

May 2013

Primary outcome: Primary: Number of Participants Responding to the Vaccine — 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 1650-G Vaccine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Edward Hirschowitz
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Responding to the Vaccine	6	—

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.

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.

View full record on ClinicalTrials.gov →

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.