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Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study

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ClinicalTrials.gov Identifier: NCT03033225
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Carcinoma Locally Advanced Pancreatic Carcinoma Metastatic Pancreatic Carcinoma Pancreatic Neoplasm Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Unresectable Pancreatic Carcinoma Procedure: Endoscopic Ultrasound Drug: Photodynamic Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Verteporfin Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)
Actual Study Start Date : December 6, 2016
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Verteporfin

Arm Intervention/treatment
Experimental: Treatment (verteporfin, EUS-guided PDT)
Patients receive verteporfin IV and after 60 minutes undergo EUS-guided PDT.
Procedure: Endoscopic Ultrasound
Undergo EUS-guided PDT
Other Names:
  • endosonography
  • EUS

Drug: Photodynamic Therapy
Undergo EUS-guided PDT
Other Names:
  • PDT
  • Photoradiation Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Verteporfin
Given IV
Other Names:
  • Benzoporphyrin Derivative Monoacid Ring A
  • BPD-MA
  • Visudyne




Primary Outcome Measures :
  1. Tumor response [ Time Frame: 12 months post photodynamic therapy (PDT) ]
    To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.



Information from the National Library of Medicine

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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

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

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): NCT03033225


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clincial Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Kenneth K. Wang         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kenneth K Wang Mayo Clinic in Rochester
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03033225    
Other Study ID Numbers: 16-001243
NCI-2019-07003 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16-001243 ( Other Identifier: Mayo Clinic in Rochester )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents