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Cancer Vaccine

Dendritic Cell Immunotherapy for Pancreatic Cancer (DECIST Trial)

Phase 1
Recruiting
Led By Benjamin Musher, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to step 2 registration: Hemoglobin greater than/equal to 8 gm/dL; Absolute neutrophil count (ANC) greater than/equal to 1,500 cells/mm3; Platelet count greater than/equal to 75,000/mm3; Total bilirubin less than/equal to 1.5 times upper limit of normal (ULN); Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) less than/equal to 2.5 times the ULN; TSH range between 0.4-4.0 mIU/L; RF less than/equal to 15 IU/ml; Peripheral CD4+ t-cell greater than 200/ul.
ECOG performance status less than/equal to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment start until 6 weeks after.
Awards & highlights

DECIST Trial Summary

This trial is testing a new vaccine for pancreatic cancer. It will test how safe and effective the vaccine is in people.

Who is the study for?
Adults over 18 with pancreatic adenocarcinoma that's potentially removable and who've finished standard chemo and surgery. They must have good organ function, no HIV, Hepatitis B or C (with exceptions), no autoimmune diseases, not be on steroids/immunosuppressants recently, and agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
This phase 1 trial tests the safety of a dendritic cell vaccine for pancreatic cancer patients. It involves escalating doses given three times post-standard treatments to see how well patients tolerate it.See study design
What are the potential side effects?
As this is an early-stage trial focusing on safety, specific side effects are not listed but may include typical immune responses such as fever, fatigue, injection site reactions or flu-like symptoms.

DECIST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood tests for kidney, liver, and immune function are within normal ranges.
Select...
I can take care of myself but might not be able to do heavy physical work.

DECIST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment start until 6 weeks after.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start until 6 weeks after. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccines
Number of participants who experienced Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Overall Survival
Time to Recurrence

DECIST Trial Design

6Treatment groups
Experimental Treatment
Group I: Autologous DC Vaccine Cohort 6Experimental Treatment1 Intervention
Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination. DC Vaccine dose evaluated in Cohort 6: st vaccine - 8 million cells nd vaccine - 8 million cells rd vaccine - 8 million cells At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.
Group II: Autologous DC Vaccine Cohort 5Experimental Treatment1 Intervention
Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination. DC Vaccine dose evaluated in Cohort 5: st vaccine - 7 million cells nd vaccine - 7 million cells rd vaccine - 7 million cells At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.
Group III: Autologous DC Vaccine Cohort 4Experimental Treatment1 Intervention
Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination. DC Vaccine dose evaluated in Cohort 4: st vaccine - 6 million cells nd vaccine - 6 million cells rd vaccine - 6 million cells At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.
Group IV: Autologous DC Vaccine Cohort 3Experimental Treatment1 Intervention
Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination. DC Vaccine dose evaluated in Cohort 3: st vaccine - 2 million cells nd vaccine - 4 million cells rd vaccine - 8 million cells At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.
Group V: Autologous DC Vaccine Cohort 2Experimental Treatment1 Intervention
Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination. DC Vaccine dose evaluated in Cohort 2: st vaccine - 1 million cells nd vaccine - 2 million cells rd vaccine - 4 million cells At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.
Group VI: Autologous DC Vaccine Cohort 1Experimental Treatment1 Intervention
Vaccine made from autologous dendritic cells loaded with tumor cell lysate and RNA. Subject will get 3 doses of DC vaccine (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During treatment, subjects get weekly peg-interferon a-2a at 180 mcg/week on the first day of vaccination up through 14 days after last vaccination. DC Vaccine dose evaluated in Cohort 1: st vaccine - 0.5 million cells nd vaccine - 1 million cells rd vaccine - 2 million cells At each dose level, the 1st subject should get all 3 vaccinations before the 2nd and 3rd subjects at that level receive their 1st vaccination. The 3rd subject can begin vaccination regardless of the time since the 2nd subject began vaccinations. All 3 subjects in cohort should get all 3 vaccinations before any subjects are treated in the next higher cohort. Because of this, the study may not progress to every dose level before MTD is found.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,209 Total Patients Enrolled
Cancer Cures for KidsUNKNOWN
Benjamin Musher, MDPrincipal InvestigatorBaylor College of Medicine
1 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

Autologous DC vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04157127 — Phase 1
Pancreatic Cancer Research Study Groups: Autologous DC Vaccine Cohort 2, Autologous DC Vaccine Cohort 3, Autologous DC Vaccine Cohort 4, Autologous DC Vaccine Cohort 5, Autologous DC Vaccine Cohort 6, Autologous DC Vaccine Cohort 1
Pancreatic Cancer Clinical Trial 2023: Autologous DC vaccine Highlights & Side Effects. Trial Name: NCT04157127 — Phase 1
Autologous DC vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04157127 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for patient enrollment in this clinical trial?

"As per clinicaltrials.gov, this experiment is still open for recruitment. This research project was initially advertised on August 3rd 2020 and its details were most recently updated a few days ago on 17th of August 2022."

Answered by AI

How many participants are taking part in this clinical research?

"Affirmative. According to clinicaltrials.gov, this medical study is actively looking for participants since it was first published on August 3rd 2020 and the most recent edit being made on August 17th 2022. The trial necessitates 43 subjects from three different facilities."

Answered by AI

Does Autologous DC vaccine pose any risks to patients?

"The existing data on Autologous DC vaccine's safety and efficacy is limited, thus it received the lowest score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
Benjamin Leon Musher 2020. "Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04157127.
~13 spots leftby Jan 2026
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