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New treatment option for Pancreatic Adenocarcinoma
Official title Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT04157127
What this study is testing
What is Autologous DC Therapy?
Autologous DC Therapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pancreatic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- An individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18 years and older
- Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or...
- Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unresectable or metastatic (stage IV) pancreatic cancer.
- Patients with known HIV and a positive viral load.
- Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C...
- Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex...
- Rash that covers less than 10 % of body surface area.
See the full eligibility criteria
- An individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18 years and older
- Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include...
- Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
- Hemoglobin ≥ 8.0 gm/dL
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelet count ≥ 75,000 /mm3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
- Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
- ECOG performance status ≤ 2.
- For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and...
- WOCBP must have a negative serum pregnancy prior to vaccination
- 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...
- Patient must agree to not donate blood for up to 90 days after last vaccination.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unresectable or metastatic (stage IV) pancreatic cancer.
- Patients with known HIV and a positive viral load.
- Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded.
- Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g...
- Rash that covers less than 10 % of body surface area.
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral...
- Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.
- Female patients who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test within 28 days (or decline contraception requirements as outlined above). Post-menopausal women must be...
- 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, active systemic...
- Requires chronic treatment with a systemic steroid (⩾10 mg/day of prednisone equivalent) or with any systemic immunosuppressive agent.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.