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
Conditions
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.
Interventions
PROCEDUREEndoscopic Ultrasound
Undergo EUS-guided PDT
PROCEDUREFluorescence Imaging
Undergo fluorescence imaging
DRUGPhotodynamic Therapy
Undergo EUS-guided PDT
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
DRUGVerteporfin
Given IV
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT | Assessed by the number of participants who did or did not respond, evaluated by tumor necrosis as a function of delivered energy, based on pre-photodynamic therapy (PDT) contrast computed tomography (CT) scans. Tumor volume response was graded per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CT scans were obtained on day 2 following PDT. Most patients (87.5%) had a repeat CT of the abdomen and pelvis for reasons unrelated to the study; these CTs were also reviewed for tumor response. |
Countries
United States
Participant flow
Recruitment details
Between March 15, 2017 and July 20, 2019, 623 potential patients were examined for eligibility. Of these, 54 were confirmed eligible and approached for consideration. Eight participants proceeded to inclusion/study completion. Reasons for nonparticipation included nonresponse, unsuitable timing of study (for personal reasons or decision to initiate a chemotherapeutic agent), unsuitable location of study/unwillingness to travel to study site, and entry into a different research study.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Verteporfin, EUS-guided PDT) Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Treatment (Verteporfin, EUS-guided PDT) |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Tumor Response
Assessed by the number of participants who did or did not respond, evaluated by tumor necrosis as a function of delivered energy, based on pre-photodynamic therapy (PDT) contrast computed tomography (CT) scans. Tumor volume response was graded per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CT scans were obtained on day 2 following PDT. Most patients (87.5%) had a repeat CT of the abdomen and pelvis for reasons unrelated to the study; these CTs were also reviewed for tumor response.
Time frame: Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Verteporfin, EUS-guided PDT) | Tumor Response | PDT Response | 5 Participants |
| Treatment (Verteporfin, EUS-guided PDT) | Tumor Response | PDT Non-response | 3 Participants |