NCT01258868

Tumor Cell Vaccines With ISCOMATRIX Adjuvant and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers and Malignant Pleural Mesotheliomas

Terminated Phase 1 Last updated 3 December 2019

What this trial tests

Phase 1 trial testing Celebrex in Mesolthelioma in 44 participants. Terminated before completion.

Timeline

1 December 2010

Primary endpoint
13 June 2016

13 June 2016

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 December 2010
Primary completion	13 June 2016
Estimated completion	13 June 2016
Sites	1 location across United States

Drugs / interventions tested

• Celebrex (celecoxib) — full drug profile →
• Tumor cell vaccine — full drug profile →

Conditions studied

• Mesolthelioma — all drugs for Mesolthelioma →
• Esophageal Cancer — all drugs for Esophageal Cancer →
• Lung Cancer — all drugs for Lung Cancer →
• Thoracic Sarcomas — all drugs for Thoracic Sarcomas →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Mesolthelioma or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Recent research has shown that causing an immune response to tumor cells may help slow or stop the growth of tumors. One treatment that has come from this research involves collecting and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to the patient as a vaccine to encourage the immune system to respond to them. Researchers are interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which can be added to a vaccine in order to elicit a stronger immune response in the body. ISCOMATRIX has not been approved for sale and use in any country and its use is still experimental, though it has been tested and used safely in other clinical studies. Researchers are also interested in determining whether the anti-inflammatory drug celecoxib will improve the body's immune reaction if given with the vaccine.

Objectives:

\- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and celecoxib in the treatment of lung and esophagus cancers.

Eligibility:

* Individuals at least 18 years of age who have primary small cell or non-small cell lung cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery.
* Only individuals whose tumor cells are able to produce a tumor cell line for vaccine development will be eligible for treatment.

Design:

* Participants will be screened with a physical examination and medical history, and will have tumor tissue collected during their surgery to determine whether the tumor cells can be used to produce a vaccine.
* Participants will take celecoxib twice daily for 7 days before having the first tumor cell vaccination. Participants will also have leukapheresis to collect blood cells for testing before the first vaccination.
* Participants will receive one vaccine (which may be given in two shots) monthly for 6 months, and will continue to take celecoxib twice daily. One month after the 6th vaccine shot, participants will have another leukapheresis and skin test. If these tests show that a participant is responding to the vaccine, additional vaccines will be given every 3 months for up to 2 years.
* Participants will have a physical exam and lab tests before each vaccination, blood samples and imaging studies every 3 months, and a skin test every 6 months.
* Participants will have regular followup visits with imaging studies and blood samples for up to 5 years after the first vaccination, or until a new tumor develops.

Publications & conference data

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

1. Immunomodulatory Nanosystems.
   Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101
2. Molecular pathways and therapeutic targets in lung cancer.
   Shtivelman E, Hensing T, Simon GR, Dennis PA, et al · · 2014 · cited 150× · PMID 24722523 · DOI 10.18632/oncotarget.1891
3. Engineered tumor cell-derived vaccines against cancer: The art of combating poison with poison.
   Zhang X, Cui H, Zhang W, Li Z, et al · · 2023 · cited 54× · PMID 36330160 · DOI 10.1016/j.bioactmat.2022.10.016
4. Trial Watch-Small molecules targeting the immunological tumor microenvironment for cancer therapy.
   Buqué A, Bloy N, Aranda F, Cremer I, et al · · 2016 · cited 44× · PMID 27471617 · DOI 10.1080/2162402x.2016.1149674
5. Latest developments in our understanding of the pathogenesis of mesothelioma and the design of targeted therapies.
   Bononi A, Napolitano A, Pass HI, Yang H, et al · · 2015 · cited 38× · PMID 26308799 · DOI 10.1586/17476348.2015.1081066
6. Translational nanoparticle engineering for cancer vaccines.
   Grippin AJ, Sayour EJ, Mitchell DA. · · 2017 · cited 33× · PMID 29123947 · DOI 10.1080/2162402x.2017.1290036
7. Is immunotherapy in the future of therapeutic management of sarcomas?
   Clemente O, Ottaiano A, Di Lorenzo G, Bracigliano A, et al · · 2021 · cited 24× · PMID 33902630 · DOI 10.1186/s12967-021-02829-y
8. The emerging nanomedicine-based technology for non-small cell lung cancer immunotherapy: how far are we from an effective treatment.
   Peng L, Xu Q, Yin S, Zhang Y, et al · · 2023 · cited 2× · PMID 37182180 · DOI 10.3389/fonc.2023.1153319