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

Launched by DIAKONOS ONCOLOGY CORPORATION · Nov 6, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of treatment for pancreatic cancer called Th-1 dendritic cell immunotherapy, combined with standard chemotherapy. It's a phase 1 study, which means it's the first time this treatment is being tested in people to see if it's safe and how well it works. Participants will receive three doses of the DC vaccine aimed at helping their immune system fight the cancer. The study is currently active but not recruiting new participants.

To be eligible for this trial, patients must be at least 18 years old and have a specific type of pancreatic cancer that doctors believe can be treated with surgery and chemotherapy. They should not have cancer that has spread too far or any serious infections like HIV or hepatitis. Eligible participants can expect to undergo a thorough evaluation and, if they qualify, receive the new treatment along with standard care. It's important for women of childbearing age to use effective birth control during the study, and patients will need to follow certain health guidelines to ensure their safety throughout the trial.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• An individual must meet all of the following criteria:
• • 1. Provision of signed and dated informed consent form
• • 2. Male or female, aged 18 years and older
• • 3. 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 patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection.
• 4. Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
• • 1. Hemoglobin ≥ 8.0 gm/dL
• • 2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• • 3. Platelet count ≥ 75,000 /mm3
• • 4. Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
• • 5. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
• • 5. ECOG performance status ≤ 2.
• • 6. 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 continue for at least 12 weeks after her last vaccination.
• • 7. WOCBP must have a negative serum pregnancy prior to vaccination
• • 8. 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.
• • 9. Patient must agree to not donate blood for up to 90 days after last vaccination.
• • Exclusion Criteria
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Unresectable or metastatic (stage IV) pancreatic cancer.
• • 2. Patients with known HIV and a positive viral load.
• • 3. 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.
• 4. 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. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met:
• • 1. Rash that covers less than 10 % of body surface area.
• • 2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
• • 3. 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 corticosteroids within the previous 12 months.
• • 5. Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.
• • 6. 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 amenorrheic for at least 12 months to be considered of non-childbearing potential.
• • 7. Patients unwilling or unable to comply with the protocol or provide informed consent.
• • 8. 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 autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.
• • 9. Requires chronic treatment with a systemic steroid (⩾10 mg/day of prednisone equivalent) or with any systemic immunosuppressive agent.