NCT01143545

Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas

Terminated Phase 1 Last updated 3 March 2020

What this trial tests

Phase 1 trial testing Allogeneic Tumor Cell Vaccine (K562) in Lung Cancer in 10 participants. Terminated before completion.

Timeline

7 December 2010

Primary endpoint
9 February 2015

26 February 2020

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	10
Start date	7 December 2010
Primary completion	9 February 2015
Estimated completion	26 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Allogeneic Tumor Cell Vaccine (K562) — full drug profile →
• Celecoxib (celecoxib) — full drug profile →
• cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Esophageal Cancer — all drugs for Esophageal Cancer →
• Malignant Pleural Mesothelioma — all drugs for Malignant Pleural Mesothelioma →
• Sarcoma — all drugs for Sarcoma →

Sponsor

National Cancer Institute (NCI)

Who can join

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

Sponsor's own description

Background:

\- Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from growing. Researchers are also interested in determining whether the chemotherapy drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work better, particularly in patients with lung cancer.

Objectives:

\- To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest.

Eligibility:

\- Individuals at least 18 years of age who have had surgery for small cell or non-small cell lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural mesothelioma.

Design:

* Following recovery from surgery, chemotherapy, or radiation, participants will have leukapheresis to collect lymphocytes (white blood cells) for testing.
* Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7 days before the vaccine.
* Participants will have the vaccine in the clinical center (one or two shots per month for 6 months), and will stay in the clinic for about 4 hours after the vaccine. Participants will keep a diary at home of any side effects from the vaccine, and will continue to take cyclophosphamide and celecoxib.
* One month after the sixth vaccine, participants will provide another blood sample for testing, and if the tests are satisfactory will return to the clinic every 3 months for 2 additional vaccines.
* Participants will return to clinic for follow-up physical examinations, lab tests, and scans every 3 months for 2 years and then every 6 months for up to 3 years.

Publications & conference data

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

1. Chemotherapy-induced immunomodulation in non-small-cell lung cancer: a rationale for combination chemoimmunotherapy.
   Zheng H, Zeltsman M, Zauderer MG, Eguchi T, et al · · 2017 · cited 52× · PMID 29338609 · DOI 10.2217/imt-2017-0052
2. 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
3. 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
4. Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations.
   Zhang K, Demner-Fushman D. · · 2017 · cited 31× · PMID 28339690 · DOI 10.1093/jamia/ocw176
5. New roads open up for implementing immunotherapy in mesothelioma.
   Cornelissen R, Heuvers ME, Maat AP, Hendriks RW, et al · · 2012 · cited 16× · PMID 22778767 · DOI 10.1155/2012/927240
6. Clinical Applications of Combined Immunotherapy Approaches in Gastrointestinal Cancer: A Case-Based Review.
   Eralp Y, Ates U. · · 2023 · cited 2× · PMID 37896948 · DOI 10.3390/vaccines11101545
7. Changing Landscape of Cancer Vaccines-Novel Proteomics Platform for New Antigen Compositions.
   Lokhov PG, Lichtenberg S, Balashova EE. · · 2022 · cited 2× · PMID 35457221 · DOI 10.3390/ijms23084401