NCT01313429

Tumor Cell Vaccine for Patients Undergoing Surgery for Sarcomas, Melanomas, Germ Cell Tumors, or Malignancies That Have Metastasized to the Lungs, Pleura, or Mediastinum

Terminated Phase 1 Last updated 3 March 2020

What this trial tests

Phase 1 trial testing Cyclophosphamide in Sarcoma in 19 participants. Terminated before completion.

Timeline

4 March 2011

Primary endpoint
26 February 2020

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	19
Start date	4 March 2011
Primary completion	26 February 2020
Estimated completion	26 February 2020
Sites	1 location across United States

Drugs / interventions tested

• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Allogenic tumor Cell Vaccine (K562) — full drug profile →
• Celecoxib (celecoxib) — full drug profile →

Conditions studied

• Sarcoma — all drugs for Sarcoma →
• Melanoma — all drugs for Melanoma →
• Epithelial Malignancies — all drugs for Epithelial Malignancies →
• Pleural Malignancies — all drugs for Pleural Malignancies →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Sarcoma or Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Certain types of cancers, including sarcoma and melanoma, have specific antigens (protein molecules) on their surfaces. Research has shown that producing an immune reaction to these antigens may be able to keep tumors from growing by encouraging the immune system to destroy the tumor cells. By creating a vaccine that contains antigens similar to those found on the cancer cells, researchers hope to cause an immune reaction that targets the cancer cells. However, more research is needed to determine the safety and effectiveness of this type of vaccine treatment.

Objectives:

\- To determine whether a tumor cell vaccine, given to individuals who have had surgery to remove malignant tumors from the chest, can cause an immune reaction that will prevent the tumors from coming back.

Eligibility:

\- Individuals at least 18 years of age who have been diagnosed with cancer that has spread to the lungs, pleura, or mediastinum, and have recently had surgery to remove tumors in the chest.

Design:

* Participants will be screened with a physical examination and medical history, as well as blood tests and imaging studies.
* Participants will have the option to have leukapheresis to collect white blood cells for studies on how the body is responding to the vaccine. Participants who agree to have this procedure will have it before the start of treatment and after the sixth and eighth vaccines.
* Seven days before the first vaccine, participants will receive the chemotherapy drugs celecoxib and cyclophosphamide to take twice a day at home.
* Participants will receive the experimental vaccine as an injection in the thigh or arm, and may receive it in two shots depending on how many cells are in each vaccine. Participants will receive a diary to monitor medication doses and side effects, as well as additional cyclophosphamide and celecoxib to take at home as directed by the study.
* Participants will have one vaccine every month for 6 months, and will have regular blood tests and imaging studies. After the sixth vaccine, participants who have successfully responded to the treatment will have two additional vaccines given 3 months apart.
* After the eighth vaccine, participants will have followup visits every 3 months for 1 year and then every 6 months for up to 4 years....

Publications & conference data

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

1. Lipid metabolic Reprogramming: Role in Melanoma Progression and Therapeutic Perspectives.
   Pellerin L, Carrié L, Dufau C, Nieto L, et al · · 2020 · cited 65× · PMID 33121001 · DOI 10.3390/cancers12113147
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. Whole-Cell Cancer Vaccines Induce Large Antibody Responses to Carbohydrates and Glycoproteins.
   Xia L, Schrump DS, Gildersleeve JC. · · 2016 · cited 43× · PMID 27889407 · DOI 10.1016/j.chembiol.2016.10.012
4. Case report: whole exome sequencing of primary cardiac angiosarcoma highlights potential for targeted therapies.
   Zhrebker L, Cherni I, Gross LM, Hinshelwood MM, et al · · 2017 · cited 20× · PMID 28056866 · DOI 10.1186/s12885-016-3000-z
5. The war between the immune system and the tumor - using immune biomarkers as tracers.
   Yang K, Lu R, Mei J, Cao K, et al · · 2024 · cited 9× · PMID 38816871 · DOI 10.1186/s40364-024-00599-5
6. 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