Back to resultsUltrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
Primary Purpose
Advanced Pancreatic Carcinoma, Locally Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Ultrasound
Fluorescence Imaging
Photodynamic Therapy
Quality-of-Life Assessment
Questionnaire Administration
Verteporfin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Pancreatic Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histological/cytological diagnosis (Dx) of advanced or locally advanced or small volume metastatic pancreatic cancer (PanCa) or other solid pancreatic tumor that is not amenable to curative surgical resection, or the patient is unfit, or declines surgery
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Estimated life expectancy of at least 12 weeks
- Capable of giving written informed consent
- Adequate biliary drainage (serum bilirubin < 2.5 upper limit of normal [ULN]), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
- Women of child-bearing potential with a negative pregnancy test (qualitative serum human chorionic gonadotropin [HCG]) prior to study entry AND must be using an adequate contraception method, which must be continued for 1 week after PDT
Exclusion Criteria:
- For locally advanced patients, evidence of metastases other than lung or liver. For lung metastases, greater than three lesions and any lesions greater than 5 cm are excluded. For advanced patients, any metastasis is acceptable for enrollment
- Porphyria
- Pregnant or breast-feeding
- Locally advanced disease involving > 50% circumference of the duodenum or a major artery within the treatment area
- ECOG performance status 3 or 4
- Previous treatment with curative intent for current disease within the past two weeks (i.e. prior resection, radical radiotherapy or chemotherapy)
- Any psychiatric disorder making reliable informed consent impossible
- A history of documented hemorrhagic diathesis or coagulopathy on therapeutic anticoagulation
- History of prior or concomitant other malignancy that will interfere with the response evaluation
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- Contrast allergy not amenable to treatment with steroids and antihistamines
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (verteporfin, EUS-guided PDT)
Arm Description
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
Outcomes
Primary Outcome Measures
Tumor response
To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
Secondary Outcome Measures
Full Information
NCT ID
NCT03033225
First Posted
January 24, 2017
Last Updated
September 5, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03033225
Brief Title
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
Official Title
Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2016 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
This phase II trial studies how well ultrasound-guided verteporfin photodynamic therapy works for the treatment of patients with solid pancreatic tumors that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (advanced). Photodynamic therapy is a type of laser device that is guided by ultrasound imaging and used in combination with the drug verteporfin that may be less invasive and as effective as current treatment methods for patients with pancreatic cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. To show that endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) to the pancreas is effective at direct ablation of advanced or locally advanced and small volume metastatic pancreatic tumors in a multicenter setting.
SECONDARY OBJECTIVE:
I. To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
TERTIARY OBJECTIVE:
I. Evaluate the safety of chemotherapy given two days after PDT.
QUARTERNARY OBJECTIVE:
I. Demonstrate that cancer biomarkers in pre- versus (vs.) post-PDT are surrogate markers of response.
OUTLINE:
Patients receive verteporfin intravenously (IV) and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
After completion of study treatment, patients are followed up at 14 days, and at 3, 6, and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Carcinoma, Locally Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Pancreatic Neoplasm, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (verteporfin, EUS-guided PDT)
Arm Type
Experimental
Arm Description
Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Ultrasound
Other Intervention Name(s)
endosonography, EUS
Intervention Description
Undergo EUS-guided PDT
Intervention Type
Procedure
Intervention Name(s)
Fluorescence Imaging
Intervention Description
Undergo fluorescence imaging
Intervention Type
Drug
Intervention Name(s)
Photodynamic Therapy
Other Intervention Name(s)
PDT, Photoradiation Therapy
Intervention Description
Undergo EUS-guided PDT
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Other Intervention Name(s)
Benzoporphyrin Derivative Monoacid Ring A, BPD-MA, Visudyne
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Tumor response
Description
To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.
Time Frame
12 months post photodynamic therapy (PDT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological/cytological diagnosis (Dx) of advanced or locally advanced or small volume metastatic pancreatic cancer (PanCa) or other solid pancreatic tumor that is not amenable to curative surgical resection, or the patient is unfit, or declines surgery
Age > 18 years
Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Estimated life expectancy of at least 12 weeks
Capable of giving written informed consent
Adequate biliary drainage (serum bilirubin < 2.5 upper limit of normal [ULN]), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
Women of child-bearing potential with a negative pregnancy test (qualitative serum human chorionic gonadotropin [HCG]) prior to study entry AND must be using an adequate contraception method, which must be continued for 1 week after PDT
Exclusion Criteria:
For locally advanced patients, evidence of metastases other than lung or liver. For lung metastases, greater than three lesions and any lesions greater than 5 cm are excluded. For advanced patients, any metastasis is acceptable for enrollment
Porphyria
Pregnant or breast-feeding
Locally advanced disease involving > 50% circumference of the duodenum or a major artery within the treatment area
ECOG performance status 3 or 4
Previous treatment with curative intent for current disease within the past two weeks (i.e. prior resection, radical radiotherapy or chemotherapy)
Any psychiatric disorder making reliable informed consent impossible
A history of documented hemorrhagic diathesis or coagulopathy on therapeutic anticoagulation
History of prior or concomitant other malignancy that will interfere with the response evaluation
Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
Contrast allergy not amenable to treatment with steroids and antihistamines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinay Chandrasekhara
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Vinay Chandrasekhara, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34261044
Citation
Vincent P, Maeder ME, Hunt B, Linn B, Mangels-Dick T, Hasan T, Wang KK, Pogue BW. CT radiomic features of photodynamic priming in clinical pancreatic adenocarcinoma treatment. Phys Med Biol. 2021 Aug 23;66(17):10.1088/1361-6560/ac1458. doi: 10.1088/1361-6560/ac1458.
Results Reference
derived
PubMed Identifier
33647286
Citation
Hanada Y, Pereira SP, Pogue B, Maytin EV, Hasan T, Linn B, Mangels-Dick T, Wang KK. EUS-guided verteporfin photodynamic therapy for pancreatic cancer. Gastrointest Endosc. 2021 Jul;94(1):179-186. doi: 10.1016/j.gie.2021.02.027. Epub 2021 Feb 26.
Results Reference
derived
Learn more about this trial
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
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