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Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (DECIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04157127
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Cancer Cures for Kids
Information provided by (Responsible Party):
Benjamin Leon Musher, Baylor College of Medicine

Study Description
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Brief Summary:
This is a phase 1, first in man, dose escalation study for safety and feasibility for administration of 3 doses of DC vaccine for pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Pancreatic Cancer Biological: Autologous DC vaccine Phase 1

Detailed Description:

The primary objective of this phase 1, first in man trial is to determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with pancreatic adenocarcinoma lysate plus mRNA to pancreatic cancer patients as adjuvant therapy following completion of standard chemotherapy.

Patients will first complete standard treatment for pancreatic adenocarcinoma which is surgically resectable and then within 3 months of finishing chemotherapy, they will have three doses of the dendritic cell vaccine by perinodal injection using ultrasound guidance.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single-arm, open-label study where all subjects will receive the DC vaccine. The amount of cells in the vaccine will vary based on the cohort determination and dose escalation schema. Six arms are specified to allow differentiation of the cohorts and their respective dose levels.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous DC Vaccine Cohort 1

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-2b at 1.5 mcg/kg on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 1:

  1. st vaccine - 0.5 million cells
  2. nd vaccine - 1 million cells
  3. 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.

 Biological: Autologous DC vaccine
Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.
Experimental: Autologous DC Vaccine Cohort 2

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-2b at 1.5 mcg/kg on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 2:

  1. st vaccine - 1 million cells
  2. nd vaccine - 2 million cells
  3. 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.

 Biological: Autologous DC vaccine
Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.
Experimental: Autologous DC Vaccine Cohort 3

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-2b at 1.5 mcg/kg on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 3:

  1. st vaccine - 2 million cells
  2. nd vaccine - 4 million cells
  3. 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.

 Biological: Autologous DC vaccine
Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.
Experimental: Autologous DC Vaccine Cohort 4

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-2b at 1.5 mcg/kg on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 4:

  1. st vaccine - 6 million cells
  2. nd vaccine - 6 million cells
  3. 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.

 Biological: Autologous DC vaccine
Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.
Experimental: Autologous DC Vaccine Cohort 5

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-2b at 1.5 mcg/kg on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 5:

  1. st vaccine - 7 million cells
  2. nd vaccine - 7 million cells
  3. 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.

 Biological: Autologous DC vaccine
Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.
Experimental: Autologous DC Vaccine Cohort 6

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-2b at 1.5 mcg/kg on the first day of vaccination up through 14 days after last vaccination.

DC Vaccine dose evaluated in Cohort 6:

  1. st vaccine - 8 million cells
  2. nd vaccine - 8 million cells
  3. 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.

 Biological: Autologous DC vaccine
Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.


Outcome Measures
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Primary Outcome Measures :
  1. MTD of DC Vaccine [ Time Frame: From treatment start until 6 weeks after. ]
    Maximum tolerated dose of dendritic cell vaccine following completion of surgery and standard adjuvant chemotherapy, as determined by BOIN design. DLTs were defined as shown in the subsequent Primary Outcome Measure.

  2. Number of participants who experienced Dose Limiting Toxicities (DLTs) [ Time Frame: From treatment start until 6 weeks after. ]
    A DLT is defined as any non-hematologic toxicity of grade 3 or 4 by the Common Terminology Criteria for Adverse Events Version 5.x (CTCAE 5.x) that was probably or definitely DC-vaccine related. Certain grade 4 hematologic toxicities that are probably or definitely DC-vaccine related are also considered DLTs.


Secondary Outcome Measures :
  1. Time to Recurrence [ Time Frame: From surgery until recurrence or up to 3 years after surgery, whichever comes first. ]
    Measurement of time from resection surgery to recurrence of pancreatic adenocarcinoma.

  2. Overall Survival [ Time Frame: From surgery until death or up to 3 years after surgery, whichever comes first. ]
    Measurement of time from resection surgery to death.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Step 1 Inclusion Criteria:

  • Provision of signed and dated informed consent form for Step 1
  • Male or female, aged 18 years and older
  • Diagnosed with adenocarcinoma of the pancreas deemed to be potentially resectable and who are deemed to be good candidate for postoperative adjuvant chemotherapy. This may include patients whose tumors are deemed suitable for upfront resection as well as patients whose tumors are deemed borderline resectable and thus undergo neoadjuvant therapy prior to resection. Note: women of child-bearing potential must be on birth control for 30 days prior to first vaccination; it is recommended to discuss this requirement with subjects at Step 1.

Step 1 Exclusion Criteria:

  • Locally advanced tumors deemed un-resectable and/or metastatic tumors
  • Patients with known HIV positivity
  • Patients with active HBV and HCV infection
  • Patients with any history of autoimmune disease
  • History of concussion

Step 2 Inclusion Criteria:

  • Provision of signed and dated informed consent form for Step 2
  • Must have undergone standard adjuvant/neo-adjuvant chemotherapy and surgery, as deemed by Investigator.
  • Must have completed standard care within 6 weeks of step 2 registration.
  • Must have adequate tissue obtained from surgery, as determined and confirmed by Dr. Decker.
  • 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.
  • Negative Hepatitis B and C serology. Positive HBs Ab indicating immunity is not exclusionary.
  • ECOG performance status less than/equal to 2
  • For women of child bearing potential (WOCBP): At the time or (or prior to) registration to Step 2, use of highly effective contraception must be discussed with participant. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after his/her last vaccination.
  • WOCBP must have a negative serum pregnancy within 28 days of registration to step 2.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.
  • Patient must agree to not donate blood for up to 90 days after last vaccination.

Step 2 Exclusion Criteria:

  • Use of nonstandard adjuvant chemotherapy regimen, as determined by the Investigator.
  • Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test within 28 days of registration to Step 2 (or decline contraception requirements as outlined above). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Patients unwilling or unable to comply with the protocol or provide informed consent.
  • Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to: hyper/hypothyroidism, systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.
  • Treatment with a systemic steroid or with any systemic immunosuppressive agent within 7 days of step 2 registration.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157127


Contacts
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Contact: Benjamin Musher, MD 713-798-4292 blmusher@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Medical Center - McNair Campus Recruiting
Houston, Texas, United States, 77030
Contact: Benjamin Musher, MD    713-798-4292    blmusher@bcm.edu   
Baylor St. Lukes Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Benjamin Musher    713-798-4292    blmusher@bcm.edu   
Dan L. Duncan Cancer Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor    713-798-1297      
Sponsors and Collaborators
Baylor College of Medicine
Cancer Cures for Kids
Investigators
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Principal Investigator: Benjamin Musher, MD Baylor College of Medicine
More Information
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Responsible Party: Benjamin Leon Musher, Assistant Professor, Medicine - Hematology & Oncology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04157127    
Other Study ID Numbers: H-42434
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Leon Musher, Baylor College of Medicine:
Immunotherapy
Adjuvant therapy
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms