CD8+ T Cell Therapy and Pembrolizumab in Treating Patients With Metastatic Gastrointestinal Tumors
NCT02757391 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2020-10-30
Summary
This phase I pilot trial studies the side effects of cluster of differentiation 8 (CD8)+ T cells in treating patients with gastrointestinal tumors that have spread to other places in the body. Tumor cells and blood are used to help create an adoptive T cell therapy, such as CD8+ T cell therapy, that is individually designed for a patient and may help doctors learn more about genetic changes in the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CD8+ T cell therapy and pembrolizumab may work better in treating patients with gastrointestinal tumors.
Conditions
- Colorectal Adenocarcinoma
- Metastatic Cholangiocarcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Digestive System Carcinoma
- Metastatic Esophageal Carcinoma
- Metastatic Gastric Carcinoma
- Metastatic Pancreatic Adenocarcinoma
- Stage IV Colorectal Cancer AJCC v7
- Stage IV Esophageal Cancer AJCC v7
- Stage IV Gastric Cancer AJCC v7
- Stage IV Pancreatic Cancer AJCC v6 and v7
- Stage IVA Colorectal Cancer AJCC v7
- Stage IVB Colorectal Cancer AJCC v7
Interventions
- BIOLOGICAL
-
Adoptive Immunotherapy
Undergo CD8 +T cell therapy
- BIOLOGICAL
-
Aldesleukin
Given SC
- DRUG
-
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Michael Overman · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-09
- Primary Completion
- 2020-10-02
- Completion
- 2020-10-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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