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| ID | Type | Description | Link |
|---|---|---|---|
| 902168 | Other Grant/Funding Number | V Foundation |
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All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor | Experimental | Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC. |
|
| Stage IB/II/IIIA | Experimental | Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC. |
|
| Stage IIIA or IIIB | Experimental | Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine + PolyICLC | Biological | The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunologic response | Immunologic response will be measured by increases in anti MUC1 antibody titers post vaccination at different stages of disease: localized (Stage I, II) or locally advanced (Stage III) non-small cell lung cancer and neuroendocrine carcinoid tumors. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-MUC1 immunity | To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine | 2 years |
| Association between baseline MUC1 immunity and vaccine |
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor
All subjects must have one of the following stages: Stage IA(T1NO); IB (T2NO), II & IIIA (N2 negative); IIIA (N2+), IIIB (N3+)
Patients must have stable disease at the time of enrollment
Women and men at least 18 years of age
ECOG performance status 0-1(Appendix A)
Subjects must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease
Subjects must have acceptable organ and marrow function as defined below:
The effects of a MUC1vaccine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men and women of childbearing potential must be willing to use effective contraception (hormonal barrier method of birth control; abstinence) while on study treatment and for at least 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Exclusion Criteria:
Subjects may not be receiving any other investigational agents
- No history of prior malignancy, except for non-melanoma skin cancer
Any positive ANA titer above 1:160, even in an asymptomatic individual. Note:
Weakly positive ANA defined as ANA titers up to 1:160 maximum (≤ 1:160) will be acceptable in an asymptomatic individual who is otherwise eligible for the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Contact | 412-647-8583 | wardj@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arjun Pennathur, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
| 2 years |
| Immunocompetence versus immunosuppression | To characterize the change in the balance between immunocompetence (response of T cells to polyclonal stimulation) versus immunosuppression at different stages of disease {check for increased numbers of regulatory T cells (Treg) and Myeloid-Derived Suppressor Cells (MDSC)} | 2 years |
| MUC1 associated safety | To monitor adverse events associated with the study agents | 2 years |
| survival | To monitor for progression free survival | 2 years |
| survival | To monitor for progression of overall survival | 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |