Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer

NCT03300843 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-12-13

Study results available

Summary

Background:

Exomes are the parts of deoxyribonucleic acid (DNA) that make proteins. Researchers are finding a way to read the letters in the exome. Incorrect letters are called mutations. Tumors contain specific mutations. Researchers can find these mutations in tumors to make treatments. Researchers want to use pieces of participants tumors to find the tumor-specific mutations. They also will take participants white blood cells to make a vaccine that they hope will shrink the tumors.

Objectives:

To see if dendritic vaccine tumor-fighting cells are safe and can cause certain cancer tumors to shrink.

Eligibility:

Adults ages 18-70 who have metastatic melanoma or metastatic epithelial cancer

Design:

The first part of this study was done under protocol 03-C-0277. In that study, white blood cells and pieces of participants' tumors were taken to make a vaccine.

In this study, participants will get a vaccine every 2 weeks for 8 weeks. It will be given both in a vein and under the skin. At each visit, participants will have a physical exam and have blood taken. They will talk about any side effects they have.

After treatment ends, participants will have many follow-up visits for the first year, then once each year after that. Visits will last up to 2 days each. They will include lab tests, imaging studies, and a physical exam. Blood will be taken at each visit. At the first follow-up visit, participants may have leukapheresis, which they also had as part of protocol 03-C-0277. Participants may not have to return to the Clinical Center for these visits.

Conditions

Interventions

BIOLOGICAL

Peptide loaded dendritic cell vaccine

On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.

Sponsors & Collaborators

National Cancer Institute (NCI)
lead NIH

Principal Investigators

Steven A Rosenberg, M.D. · National Cancer Institute (NCI)

Study Design

Allocation: NA
Purpose: TREATMENT
Masking: NONE
Model: SINGLE_GROUP

Eligibility

Min Age: 18 Years
Max Age: 70 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2018-04-11
Primary Completion: 2019-07-09
Completion: 2019-09-16
FDA Drug: Yes

Countries

United States

Study Locations

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Entities

Diseases