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

Summary

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.

Conditions

• Mesolthelioma
• Esophageal Cancer
• Lung Cancer
• Thoracic Sarcomas
• Thymoma

Interventions

DRUG

Celebrex

400 mg PO BID for 7 days prior to cell administration and then on days 1 through 28 of each vaccine cycle.

BIOLOGICAL

Tumor cell vaccine

A minimum of 1x10e7 and a maximum of 1x10e8 patient tumor cells that have been exposed to 1 mcM decitabine for 6 days, exposed to 100 Gy radiation and emulsified in 0.5 ml of the ISCOMATRIX adjuvant at a concentration of 180 ISCO units/mL administered IM every 4 weeks for 6 injections; if subject shows immune response, vaccine will be given every three months from months 9 - 24

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• David S Schrump, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-01

Primary Completion

2016-06-13

Completion

2016-06-13

Countries

• United States

Study Locations