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

Edward Hirschowitz

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: 1650-G Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00654030

UKIRB 06-0716-F3R (Other Identifier)

CIRB 1079747 (Other Identifier)

ULIRB 065.07 (Other Identifier)

CTN-0505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

1650-G Vaccine

Experimental group

Description:

Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.

Treatment:

Drug: 1650-G Vaccine