Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase 2A, Dose-Finding Study of Ad5.F35-hGCC-PADRE Vaccine in Adults With Gastrointestinal Adenocarcinomas at Risk of Relapse Post Definitive Surgery and Standard Therapy
This phase IIA trial investigates the side effects of Ad5.F35-hGCC-PADRE vaccine and to see how well it works in treating patients with gastrointestinal adenocarcinoma. Ad5.F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of sequential adenovirus 5/F35-human guanylyl cyclase C-PADRE (Ad5.F35-hGCC-PADRE), delivered intramuscularly three times at three dose levels in subjects with high-risk colorectal, pancreatic, gastric, or esophageal adenocarcinomas with no evidence of disease (NED) after surgery and standard therapy. II. Evaluate the cellular (T-cell) responses to Ad5.F35-hGCC-PADRE at three different dose levels (10^11, 10^12, and 5 x 10^12 vp) administered intramuscularly three times, four weeks apart in subjects with high-risk colorectal, pancreatic, gastric, or esophageal cancer with NED after surgery and standard therapy. EXPLORATORY OBJECTIVES: I. Evaluate the humoral immunologic response to guanylyl cyclase C (GCC), defined as an incremental or sustained antibody (pan-Ig) response, measured at weeks 5, 9, and 13 following the first vaccination (week 1). II. Evaluate the relationship between immunological responses to GCC and 1) neutralizing antibodies to Ad5 and Ad5.F35 and 2) GCC protein expression in tumors to assess immune tolerance. III. Evaluate disease free survival (DFS) and overall survival (OS), where feasible. OUTLINE: Patients are randomized to 1 of 3 arms. ARM A: Patients receive low dose Ad5.F35-hGCC-PADRE vaccine intramuscularly (IM) on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive medium dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity. ARM C: Patients receive high dose Ad5.F35-hGCC-PADRE vaccine IM on day 1 of weeks 1, 5, and 9 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days, and then every 3 months for at least 24 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06030427 -
Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Suspended |
NCT04060849 -
Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY
|
Phase 1 | |
| Recruiting |
NCT06192875 -
A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
|
||
| Completed |
NCT04122118 -
Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor
|
N/A | |
| Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT03168737 -
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
|
Phase 1 | |
| Active, not recruiting |
NCT06062901 -
An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT02444741 -
Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT04081298 -
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT04555837 -
Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT04983901 -
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
|
Phase 2 | |
| Active, not recruiting |
NCT04602026 -
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer
|
N/A | |
| Recruiting |
NCT04871542 -
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
|
||
| Recruiting |
NCT04592250 -
Financial Toxicity in Cancer Patients
|
||
| Recruiting |
NCT05112614 -
Role of Gut Microbiome in Cancer Therapy
|
||
| Active, not recruiting |
NCT04296305 -
Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain
|
Phase 4 | |
| Recruiting |
NCT05873608 -
Communication Issues in Patient and Provider Discussions of Immunotherapy
|
N/A | |
| Recruiting |
NCT02464696 -
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
|
N/A | |
| Recruiting |
NCT05372614 -
Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene
|
Phase 1 |