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

Launched by EDWARD HIRSCHOWITZ · Apr 4, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

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.