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3 Study Matches

PSCI #24-126 A Phase III Trial Of Perioperative Versus Adjuvant Chemotherapy For Resectable Pancreatic Cancer.

This study is for subjects who have removable pancreatic cancer. If subjects decide to take part in this study, subjects will either get the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months, or subjects will get surgery followed by FOLFIRINOX for about 6 months. After subjects finish their treatment, the subject's doctor will continue to watch them for side effects. They will check subjects in the clinic every 4 months for 2 years after you started the study. After that, they will check subjects either in the clinic or by phone every 6 months for 6 years after the subject started the study. This means that the subject will keep seeing or hearing from their doctor for 6 years after they started the study.

Subject will either get the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months, or the subjects will get surgery followed by FOLFIRINOX for about 6 months. After treatment the doctor will continue to watch for side effects. They will check on the subjects in the clinic every 4 months for 2 years after the subject started the study. After that, they will check the subject either in the clinic or by phone every 6 months for 6 years after you started the study. This means that the subject will keep seeing or hearing from your doctor for 6 years after you started the study.

Yes
 

Nelson Yee
Kelly Sentz-Brenneman - at ksentzbrenneman@pennstatehealth.psu.edu or 717-531-7417
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT04340141
STUDY00025939
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Inclusion Criteria:
Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma. TNM Stage: Tx-4, N0-1, M0*
No evidence of metastatic disease
Less than 180° interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
Age ≥ 18 years

Exclusion Criteria:
Gilbert’s Syndrome or known homozygosity for UGAT1A1*28 polymorphism
comorbid conditions that would prohibit curative-intent pancreatectomy
ECOG Performance Status greater than 0-1
Cancer
Approved drug(s)
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Hershey, PA ,

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial

This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.

Patients will have to sign the consent form to participate in the trial

Yes
 

Matthew Moyer
Matthew Moyer - at mmoyer@pennstatehealth.psu.edu or 717-531-0003, ext=287992
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03085004
STUDY00005206
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Inclusion Criteria:
Adult subjects over the age of 18.
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.

Exclusion Criteria:
Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines37 (i.e., consistent with a pseudocyst or serous cystadenoma).
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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Hershey, PA ,

PSCI 21-191: CG-745-2-08

The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.

Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed

Yes
 

Nelson Yee
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05249101
SITE00001325
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Inclusion Criteria:
Provision of informed consent prior to any study specific procedures.
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.

Exclusion Criteria:
For Phase 2, radiographic progression of tumor per RECIST 1.1 between start of first line FOLFIRINOX chemotherapy for metastatic pancreatic adenocarcinoma and randomization.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Cancer
Experimental drug compared to an approved drug
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Study Locations

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Hershey, PA ,