Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05610826
Other study ID # IRB19-1485
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 7, 2023
Est. completion date February 1, 2027

Study information

Verified date January 2024
Source University of Chicago
Contact Xavier Keutgen, MD
Phone 773-702-7125
Email xkeutgen@surgery.bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental. Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.


Description:

Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental. Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT. PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera) Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through the bloodstream. Lutetium-177 is the radionuclide in Lutathera which is a chemical that delivers strong radiation directly into your tumor cells and works by causing death of the cancerous tissues. PRRT can only be done on patients who have tumors that have the somatostatin receptors. Before being given PRRT, your treating doctor will run imaging tests to make sure your tumors have these targeted receptors. Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT. Participants will be randomized (like the flip of a coin) to one of two arms. Arm 1 is the control arm, which will undergo standard of care cytoreductive surgery (for the tumor). Arm 2 will undergo four cycles of PRRT before cytoreductive surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date February 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Metastatic Pancreatic neuroendocrine tumors (PanNET) to the liver - Well- or moderately differentiated (grade 1 or grade 2, Ki- - Ability to aim for equal or greater than 90% hepatic cytoreduction surgically - Proof of SSTR2 expression by uptake of tumor on 68Ga DOTATATE PET CT (Krenning Score on all or a majority of lesions - Age older than 18 years - No Somatostatin Analogues (SSA) or other systemic therapy for 4 weeks prior to starting PRRT, if randomized to arm 2. Exclusion Criteria: - Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%) - Previous liver-directed therapy with Yttrium-90 (TACE/TAE allowed if performed more than 12 months prior to enrollment) - Systemic therapy with Capecitabine and/or Temozolamide within 12 months of enrollment. - No tumor uptake on 68Ga DOTATATE PET CT - Liver tumor burden > 50% (as defined by CT or MRI) - Signs of early liver failure (T-Bilirubin >3, INR > 1.5, Albumin <3.0 g/dL unless prothrombin time is within the normal range) or cirrhosis or ascites - calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance - (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma - camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as - confirmatory exam). - 2. Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L - (75x103/mm3). - Known brain metastases, unless these metastases have been treated and stabilized. - Uncontrolled congestive heart failure (NYHA II, III, IV). - Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN. - Pregnancy or lactation. - For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel). - Prior external beam radiation therapy to more than 25% of the bone marrow. - Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP. - Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence. - Patients who have not provided a signed informed consent form to accept this treatment. - Poor renal function - Quality Unit language added - editorial changes

Study Design


Intervention

Procedure:
cytoreductive surgery
Cytoreductive surgery is an operation to remove as much tumor tissue as possible.
Drug:
Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT)
PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera). Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through blood.
Procedure:
Peptide receptor radionuclide therapy (PRRT)
PRRT is a molecular targeted therapy used to treat neuroendocrine tumors (NET). Molecular targeted therapies use drugs or other substances to identify and attack cancer cells while reducing harm to healthy tissue. PRRT delivers high doses of radiation to tumors in the body to destroy or slow their growth and reduce disease side effects.

Locations

Country Name City State
United States The University of Chicago Comprehensive Cancer Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival To determine whether preoperative peptide receptor radionuclide therapy (PRRT) prior to hepatic cytoreduction increases progression free survival (PFS1) (when compared to cytoreduction alone) in patients with metastatic PanNETs to the liver 2 years
Secondary Overall Survival To determine whether preoperative peptide receptor radionuclide therapy (PRRT) prior to hepatic cytoreduction increases overall survival.
(when compared to cytoreduction alone) in patients with metastatic PanNETs to the liver
2 years
Secondary Objective Response Rate To determine whether preoperative peptide receptor radionuclide therapy (PRRT) induces a significant objective response rate (according to RECIST) in the primary tumor (if available) and hepatic metastases of patients with metastatic PanNETs to the liver, thus facilitating surgical resection. 2 Years
Secondary Increase in Progression Free Survival To determine whether PRRT plus cytoreductive surgery increases PFS when compared to a historical cohort of patients undergoing PRRT only for metastatic PanNETs. 2 years
Secondary Improvement in Progression-Free Survival (PFS2) To determine whether PRRT plus cytoreduction compared to cytoreduction alone followed by PRRT once progression has occurred improves progression-free survival (PFS2) 2 years
Secondary Improvement in Overall Survival To determine whether PRRT plus cytoreduction compared to cytoreduction alone followed by PRRT once progression has occurred improves Overall Survival. 2 years
Secondary Difference in imaging characteristics To determine differences in imaging characteristics (e.g. tumor size), biochemical and molecular signatures of patients having received surgery + PRRT or surgery alone. 2 years
See also
  Status Clinical Trial Phase
Terminated NCT05435053 - Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer Phase 2
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Recruiting NCT06065891 - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05048524 - Peri-operative SLOG for Localized Pancreatic Cancer Phase 2
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT05679674 - Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer N/A
Recruiting NCT05501379 - Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Recruiting NCT04851106 - Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
Enrolling by invitation NCT04466189 - Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Recruiting NCT01411072 - Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer N/A
Active, not recruiting NCT01448668 - Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV) N/A
Completed NCT01155882 - Registry Study - Whipple at the Splenic Artery
Recruiting NCT04970056 - Pancreatic Cancer Early Detection Consortium
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Withdrawn NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1
Recruiting NCT06036563 - Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing