Clinical trialPhase 2Completed
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 11 September 2006
- Expected end
- 10 December 2022
- Enrollment
- 56 participants
- Sites
- 1
- Primary outcomes
- Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
- Sponsor
- Other
- Results posted
- 2022-09-02
- Last update
- 26 October 2023
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Brief summary public domain (ClinicalTrials.gov)
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene. There will be two cohorts of research participants: 1. Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity. 2. Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity [14 years]. Count Of Participants, Participants. Previously Vaccinated With GVAX Pancreas Vaccine (n=11): 1; GVAX Pancreas Vaccine Naive (n=45): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [16 years]. Median, Months (95% Confidence Interval). Previously Vaccinated With GVAX Pancreas Vaccine (n=11): 80.5 (22.5 to 187.8); GVAX Pancreas Vaccine Naive (n=45): 30.7 (19.3 to 40.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease-free Survival (DFS) [16 years]. Median, Months (95% Confidence Interval). Previously Vaccinated With GVAX Pancreas Vaccine (n=11): 109.5 (5.59 to NA) [NA Explanation: Upper bound confidence interval was not reached.]; GVAX Pancreas Vaccine Naive (n=45): 13.7 (5.55 to 25.1).