RECRUITING

Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer

Conditions

Non-small Cell Lung Cancer Advanced Pancreatic Adenocarcinoma Unresectable Pancreatic Cancer Ductal Adenocarcinoma of the Pancreas

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.

Official Title

Nano-SMART: An Adaptive Phase I-II Trial of AGuIX Gadolinium-based Nanoparticles With Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Centrally Located Lung Tumors and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma

Quick Facts

Study Start:2021-05-27

Study Completion:2027-09-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04789486

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. * Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction. * Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug. * No evidence of distant metastasis. * Pancreatic or central NSCLC size ≤ 5cm. * Age 18 years or older. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). * Ability to understand and follow the breathing instructions involved in the respiratory gating procedure. * Participants must have normal organ and marrow function as defined below: * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal * creatinine within normal institutional limits OR * Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. * The effects of AGuIX on the developing human fetus are unknown. For this reason, as well as the known teratogenic effects of radiation, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * Ability to understand and the willingness to sign a written informed consent document.	* Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field. * Participants who are receiving any other investigational agents. * Participants with known metastatic disease. * History of allergic reactions attributed to gadolinium-based IV contrast. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because AGuIX is contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AGuIX, breastfeeding should be discontinued if the mother is treated with AGuIX. * Severe claustrophobia or anxiety. * Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AGuIX. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy. * Presence of a duodenal stent. * Unable to undergo magnetic resonance imaging (MRI) due to any of the following: 1. Presence of MRI-incompatible metal material or devices in the human body 2. MRI-incompatible Pacemaker or defibrillator 3. Insulin pump 4. Aneurysm clip 5. Artificial heart valve 6. Cochlear implant 7. Shrapnel or gunshot injury 8. Cataract surgery with implant unsafe for MRI

Inclusion Criteria

Exclusion Criteria

* Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
* Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.
* Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug.
* No evidence of distant metastasis.
* Pancreatic or central NSCLC size ≤ 5cm.
* Age 18 years or older.
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
* Ability to understand and follow the breathing instructions involved in the respiratory gating procedure.
* Participants must have normal organ and marrow function as defined below:
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* total bilirubin within normal institutional limits
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
* creatinine within normal institutional limits OR
* Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
* The effects of AGuIX on the developing human fetus are unknown. For this reason, as well as the known teratogenic effects of radiation, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document.

* Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.
* Participants who are receiving any other investigational agents.
* Participants with known metastatic disease.
* History of allergic reactions attributed to gadolinium-based IV contrast.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because AGuIX is contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AGuIX, breastfeeding should be discontinued if the mother is treated with AGuIX.
* Severe claustrophobia or anxiety.
* Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AGuIX. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
* Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy.
* Presence of a duodenal stent.
* Unable to undergo magnetic resonance imaging (MRI) due to any of the following:
1. Presence of MRI-incompatible metal material or devices in the human body
2. MRI-incompatible Pacemaker or defibrillator
3. Insulin pump
4. Aneurysm clip
5. Artificial heart valve
6. Cochlear implant
7. Shrapnel or gunshot injury
8. Cataract surgery with implant unsafe for MRI

Contacts and Locations

Study Contact

Jonathan Leeman, MD

CONTACT

(617) 732-6452

jonathe_leeman@dfci.harvard.edu

Principal Investigator

Jonathan Leeman, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Jonathan Leeman, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-27

Study Completion Date2027-09-10

Study Record Updates

Study Start Date2021-05-27

Study Completion Date2027-09-10

Terms related to this study

Keywords Provided by Researchers

Non-small Cell Lung Cancer
Advanced Pancreatic Adenocarcinoma
Unresectable Pancreatic Cancer
Ductal Adenocarcinoma of the Pancreas

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer
Advanced Pancreatic Adenocarcinoma
Unresectable Pancreatic Cancer
Ductal Adenocarcinoma of the Pancreas