NCT00255827

A Phase I/II Study of Algenpantucel-L (HyperAcute Pancreas) an Antitumor Vaccination Using Alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Pancreatic Cancer

Completed Phase 1/Phase 2 Last updated 26 May 2020

What this trial tests

Phase 1/Phase 2 trial testing HyperAcute-Pancreatic Cancer Vaccine in Pancreatic Cancer in 7 participants. Completed in 1 September 2007.

Timeline

1 November 2005

1 September 2007

Quick facts

Lead sponsor	NewLink Genetics Corporation
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	1 November 2005
Estimated completion	1 September 2007
Sites	1 location across United States

Drugs / interventions tested

• HyperAcute-Pancreatic Cancer Vaccine — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

NewLink Genetics Corporation — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To assess the side effects, dose-limiting toxicity and maximum tolerated dose.
  Time frame: 6 months

Sponsor's own description

This 2-phase study will determine the safety of treating patients with pancreatic cancer with the genetically engineered HyperAcute-Pancreatic cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed pancreatic cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.

Patients 18 years of age or older with pancreatic cancer that has been surgically resected may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.

Participants will receive twelve vaccinations two weeks apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Monthly blood samples will be drawn during the 6 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the remaining first year (6 months) after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:

Medical history and physical examination Blood tests X-rays and various scans (nuclear medicine/CT/MRI) FACT-Hep Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, monthly during treatment, and during follow-up visits after completing the treatment. It includes questions on the severity of pancreatic cancer symptoms and the ability to perform normal activities of daily life.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanisms of T-Cell Exhaustion in Pancreatic Cancer.
   Saka D, Gökalp M, Piyade B, Cevik NC, et al · · 2020 · cited 106× · PMID 32823814 · DOI 10.3390/cancers12082274
2. From bench to bedside a comprehensive review of pancreatic cancer immunotherapy.
   Kunk PR, Bauer TW, Slingluff CL, Rahma OE. · · 2016 · cited 86× · PMID 26981244 · DOI 10.1186/s40425-016-0119-z
3. Personalized pancreatic cancer therapy: from the perspective of mRNA vaccine.
   Huang X, Zhang G, Tang TY, Gao X, et al · · 2022 · cited 61× · PMID 36224645 · DOI 10.1186/s40779-022-00416-w
4. Potential targets for pancreatic cancer immunotherapeutics.
   Dodson LF, Hawkins WG, Goedegebuure P. · · 2011 · cited 59× · PMID 21463193 · DOI 10.2217/imt.11.10
5. Gene Therapy for Pancreatic Diseases: Current Status.
   Kamimura K, Yokoo T, Terai S. · · 2018 · cited 11× · PMID 30384450 · DOI 10.3390/ijms19113415
6. Therapeutic Strategies Targeting Tumor Suppressor Genes in Pancreatic Cancer.
   Kuo KK, Hsiao PJ, Chang WT, Chuang SC, et al · · 2021 · cited 10× · PMID 34359820 · DOI 10.3390/cancers13153920
7. From Friend to Enemy: Dissecting the Functional Alteration of Immunoregulatory Components during Pancreatic Tumorigenesis.
   Wang HC, Hung WC, Chen LT, Pan MR. · · 2018 · cited 8× · PMID 30428588 · DOI 10.3390/ijms19113584
8. Pancreatic cancer gene therapy: from molecular targets to delivery systems.
   Fillat C, Jose A, Bofill-Deros X, Mato-Berciano A, et al · · 2011 · cited 8× · PMID 24212620 · DOI 10.3390/cancers3010368