← Back to Search

Nanoparticle

Nanoparticle-Enhanced Radiotherapy for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By Daniel Cagney, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤2

Eligible NSCLC patients must have no evidence of nodal involvement (N0), and disease has to be determined unresectable by a thoracic oncologist or the patient is medically inoperable

Must not have

Participants with known metastatic disease

Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that combines a nanoparticle with radiation. They want to see if it's effective and safe for treating pancreatic cancer and lung tumors.

Who is the study for?

This trial is for adults with certain types of lung or pancreatic cancer that can't be removed by surgery. Participants must have completed standard chemotherapy if they have pancreatic cancer, and their tumors should be no larger than 5cm. They need to have normal organ function, no distant metastasis, and an ECOG performance status ≤2 (which means they are able to walk and do some activities).

What is being tested?

The study tests a new treatment combining AGuIX nanoparticles with MR-guided stereotactic body radiation therapy (SBRT) for treating non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma. The goal is to see how safe this combination is and how well it works against these cancers.

What are the potential side effects?

Potential side effects may include reactions related to the gadolinium-based nanoparticles such as allergic responses or toxicity affecting organs. Side effects from radiotherapy might involve skin changes, fatigue, nausea, or inflammation in treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My lung cancer has not spread to my lymph nodes and cannot be removed by surgery.

Select...

My cancer has not spread to distant parts of my body.

Select...

My organ and bone marrow functions are normal.

Select...

My cancer is a confirmed type of pancreatic cancer.

Select...

I am 18 years old or older.

Select...

My pancreatic cancer cannot be removed by surgery.

Select...

My lung cancer or cancer spread to lungs is confirmed by tests.

Select...

I have completed 3 months of initial chemotherapy for advanced pancreatic cancer.

Select...

My lung or pancreatic cancer is 5cm or smaller.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to other parts of my body.

Select...

I do not have active ulcers or cancer invading my bowel/stomach.

Select...

I've had radiation in my chest or abdomen that overlaps with where I'd get treatment now.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I am HIV-positive and not on antiretroviral therapy.

Select...

I am not pregnant, as the study's medication may harm the baby.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2

Maximum tolerated dose (MTD) Phase 1

Secondary study objectives

Compare disease-specific survival

Compare overall survival

Overall Response Rate (ORR) at Maximum tolerated dose (MTD)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: SMART Phase 2Experimental Treatment1 Intervention

Randomized participants will receive standard of care SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT).

Group II: AGUIX + SMART Phase 2Experimental Treatment2 Interventions

Randomized participants will receive recommended phase 1 dose established for their disease group (central lung tumor or locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC) of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT).

Group III: AGUIX + SMART Phase 1Experimental Treatment2 Interventions

Dose escalation of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). Central lung tumor cohort will receive: * five fractions of stereotactic body radiation therapy (SBRT) * AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation and for patients receiving radiation over a two (2) week period with the 4th fraction of radiation . Locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC cohort, will receive: five fractions of stereotactic body radiation therapy (SBRT) * AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AGuIX

2016

Completed Phase 1

~20

Radiotherapy

2017

Completed Phase 3

~2610