Status:
COMPLETED
Trial of PalloV-CC in Colon Cancer
Lead Sponsor:
George E. Peoples
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is a phase Ib prospective, open label study evaluating the effect of vaccination on the immune microenvironment of cancers with results compared to banked tissue from historical controls. P...
Detailed Description
This is a single arm, open label, phase Ib trial of neoadjuvant vaccination in colon cancer. The primary endpoint is the safety and toxicity of the vaccine. The primary immunologic endpoint is the imp...
Eligibility Criteria
Inclusion
- Stage I-IV (resectable) colon cancer patients identified prior to their definitive surgery
- Diagnosis definitively confirmed by endoscopic biopsy with tumor tissue slides available for analysis
- Asymptomatic and capable of waiting 4 weeks prior to definitive surgery
- ECOG 0-1 performance
- Not involved in other clinical trials
- Capable of giving informed consent
Exclusion
- Symptoms of obstruction or GI bleeding that necessitate more urgent surgical intervention
- Cancer not definitively confirmed on endoscopic biopsy (i.e., Only high-grade dysplasia or adenoma identified, even if malignancy is suspected)
- Known immune deficiency disease or HIV, active HBV, or active HCV
- Steroids or other immunosuppressants received within 6 weeks of enrollment
- Any colon cancer directed treatment (chemotherapy or radiation) received or planned prior to surgical resection
- A history of any hematologic malignancy or myeloproliferative disease within 5 years prior to enrollment
- Leukopenia or neutropenia within two weeks of presentation
- ECOG \>/= 2
- Pregnancy (serum or urine HCG) or breast feeding
- Tbili \>1.8, Cr \>2, Hgb \<10, platelet count \<50,000, WBC \<2,000
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03827967
Start Date
July 20 2019
End Date
May 20 2023
Last Update
September 13 2023
Active Locations (1)
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1
Clinical Associates of Research Therapeutics of America
San Antonio, Texas, United States, 78212