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PalloV-CC in Colon Cancer

November 21, 2019

Overview

This study is looking at the effects of the PalloV CC vaccination on patients with colon cancer. The primary goals are to understand the safety of the vaccine, and to understand its impact on the tumor microenvironment.

 

Study Information

This study will have a total enrollment of 24 participants, joining the study in cohorts of six. Participants will receive the PalloV-CC weekly via injection. They will also serve as their own controls, as the study will be comparing pre- and post-treatment tissue samples. The study began on July 20th 2019 and is estimated to be completed on March 20th 2021.

 

Inclusion Criteria

 

  • Stage I-IV (resectable) colon cancer subjects 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 Criteria

 

  • 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

 

Location

This study is taking place at the Clinical Associates of Research Therapeutics of America, San Antonio, Texas, United States, 78212. For more information, or to participate, please contact Daniel Thorp on 346-315-6284 or at dthorp@cancerinsight.com. You may also contact Kathy Untermeyer, CCRC on 210-444-9363 or at kathy@cartainvestigators.com.

 

Sponsors/Collaborators

This study is sponsored by George E. Peoples and Cancer Insight, LLC. George Peoples, MD is the Principal Investigator.

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