Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

Study Overview
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Brief Summary
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Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery. We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.

Detailed Description
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This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.

Official Title
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Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer

Conditions
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Pancreatic Cancer Non-resectable

Intervention / Treatment
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* Biological: V3-P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of inoperable pancreatic cancer higher than normal of serum CA19.9 tumor marker levels (40 IU/ml) must be able to swallow tablets Exclusion Criteria: negative for CA19.9 pregnant, breast feeding women unwillingness to provide written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Daily tablet of V3-P given orally for 2 months | Biological: V3-P<br>* one tablet of V3-P given once daily for 2 months<br>* Other names: oral tableted therapeutic vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of V3-P on tumor burden | Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of V3-P | Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE. | 3 months | 
| Effect of V3-P on sugar and bilirubin levels | Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function | 3 months |