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Virus Therapy

NBTXR3 + Radiation Therapy for Pancreatic Cancer

Phase 1
Recruiting
Led By Eugene J Koay
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Amenable to undergo the endoscopic ultrasound guided injection of NBTXR3 as per investigator or treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from nbtxr3 injection to death from any cause or eos, whichever occurs first, assessed up to 1 year
Awards & highlights

Study Summary

This trial is testing a new drug, NBTXR3, to see if it can help treat pancreatic cancer when used with radiation therapy.

Who is the study for?
Adults over 18 with biopsy-proven pancreatic ductal adenocarcinoma, who've completed a specific chemotherapy regimen without distant metastasis. They must have good performance status, acceptable blood counts and organ function, not be pregnant or breastfeeding, agree to use effective contraception, and have no other active cancers or significant heart disease.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of NBTXR3 nanoparticles activated by radiation therapy in treating locally advanced or borderline-resectable pancreatic cancer. It aims to determine the optimal dose of NBTXR3 that can control the disease when combined with radiation.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with radiation therapy such as fatigue, skin irritation at the treatment site, nausea, and potential risks related to nanoparticle injections which could range from local reactions to more systemic effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am willing to undergo a special ultrasound-guided injection as my doctor advises.
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I've completed a 4-month chemotherapy for pancreatic cancer without signs of it spreading.
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I am 18 years old or older.
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My diagnosis is biopsy-proven pancreatic cancer.
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My pancreatic cancer can be measured and tracked using scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from nbtxr3 injection to death from any cause or eos, whichever occurs first, assessed up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from nbtxr3 injection to death from any cause or eos, whichever occurs first, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities
Maximum tolerated dose (MTD)
Recommended phase II dose (RP2D)
Secondary outcome measures
Determination of the feasibility of NBTXR3 injection in pancreas
Overall survival (OS)
Progression free survival (PFS)
Other outcome measures
Disease control rate
Presence of hafnium
Proportion of locally advanced subjects who undergo surgical resection after receiving NBTXR3/radiation therapy (R3/RT)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (NBTXR3, radiation therapy)Experimental Treatment2 Interventions
Patients receive NBTXR3 IT on day 1. Patients then undergo 15 fractions of radiation therapy between days 15-43 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,341 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,317 Total Patients Enrolled
Eugene J KoayPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
306 Total Patients Enrolled

Media Library

NBTXR3 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04484909 — Phase 1
Pancreatic Cancer Research Study Groups: Treatment (NBTXR3, radiation therapy)
Pancreatic Cancer Clinical Trial 2023: NBTXR3 Highlights & Side Effects. Trial Name: NCT04484909 — Phase 1
NBTXR3 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04484909 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted its stamp of approval to using Hafnium Oxide-containing Nanoparticles NBTXR3?

"Due to limited clinical data on the efficacy and safety of Hafnium Oxide-containing Nanoparticles NBTXR3, our team at Power rated it as a 1."

Answered by AI

How many test subjects are engaged in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research endeavour commenced on July 1st 2020 and was recently updated on September 28th 2022. It is hoped that 24 participants can be enrolled from a single site of invitation."

Answered by AI

Are there vacancies available for participants in this research program?

"Affirmative. According to information published on clinicaltrials.gov, the study is currently seeking participants and was initially posted on July 1st 2020 with an update made in September 28th 2022. The trial requires 24 patients from a single site."

Answered by AI
~10 spots leftby Dec 2026