Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal

Summary

Background:

\- A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a patient and then used to develop a vaccine. The vaccine will produce an immune system response to help destroy other cancer cells in the body. Researchers are studying ways to improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been used safely in other clinical studies. But it has not been studied with certain tumor cell vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth after tumor removal surgery.

Objectives:

\- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and drug therapy after tumor removal surgery.

Eligibility:

\- People at least 18 years of age who have had tumor cell vaccines developed from cells taken from surgically removed tumors.

Design:

* Patients will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
* Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily) for 7 days before the first vaccine dose.
* Patients will receive the tumor cell vaccine once a month for 6 months. They will continue to receive drug therapy throughout the vaccine treatment. Patients will be monitored with regular blood tests and imaging studies.
* After the first 6 months, patients who have an immune response to the vaccine will continue treatment with the vaccine and chemotherapy. They will also have regular blood tests and imaging studies. They will have this treatment for up to 24 months from the first vaccination or until they no longer have an immune response.
* Participants will have followup visits for up to 5 years after the first vaccination, or until the tumor returns.

Conditions

• Sarcoma
• Melanoma
• Epithelial Malignancies
• Pleural Malignancy

Interventions

BIOLOGICAL

Epigenetically Modified Autologous Tumor

5x 10\^7 autologous tumor cells emulsified in 0.5 mL ISCOMATRIX adjuvant will be administered IM every 4 weeks for 6 months

DRUG

Cyclophosphamide

50 mg PO BID for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each 4 week treatment cycle

DRUG

Celecoxib

400 mg PO BID for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each 4 week vaccine cycle.

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

2011-04-18

Primary Completion

2016-05-12

Completion

2016-07-21

Countries

• United States

Study Locations