Pancreatic Cancer Non-resectable
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALV3-P
one tablet of V3-P given once daily for 2 months
Sponsors
Immunitor LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of V3-P on tumor burden | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of V3-P | 3 months | Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE. |
| Effect of V3-P on sugar and bilirubin levels | 3 months | Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function |
Countries
Mongolia
Contacts
Primary Contactaldar Bourinbaiar, MD/PhD, PhD
Backup ContactMarina Tarakanovskaya, MD
Outcome results
None listed