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Virus Therapy
X-PACT for Advanced Cancers
Phase 1
Recruiting
Led By William Eward, MD
Research Sponsored by Immunolight, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
All toxicities from prior therapy should be ≤Grade 1 before start of study treatment. All radiation associated toxicities must have completely resolved to be considered for inclusion into the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post first 6 treatments to 2 years post last treatment
Awards & highlights
Study Summary
This trial is testing a new treatment for subjects with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma. The treatment is a intra-tumoral injection of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy). The primary objective is to establish the safety of the treatment.
Who is the study for?
Adults over 18 with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma can join this trial if their tumor is superficial (less than 5 cm deep), measurable by RECIST criteria, and accessible for injection. They must have an ECOG Performance Status of ≤1, adequate organ function, no severe allergies to psoralen compounds or the phosphor device components, not be pregnant/breastfeeding and agree to use effective contraception.Check my eligibility
What is being tested?
The X-PACT treatment involves injecting a combination product into the tumor and exposing it to X-ray energy. This Phase I trial aims to establish safety through five injections over six weeks. Patients showing stable disease or response may receive two additional boosters. Safety will be determined if ≤2 out of 12 patients experience dose-limiting toxicity post-treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to intra-tumoral injections such as pain at the injection site, inflammation around the tumor area, possible skin sensitivity due to methoxsalen exposure under X-ray energy which could lead to burns or rashes on treated areas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor can be reached for treatment either directly or with imaging guidance.
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My side effects from previous treatments are mild or gone.
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80% of my tumor can be reached for treatment with an injection.
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I am 18 years old or older.
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My cancer does not involve my eyes or brain.
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My tumor is on the surface and not deeper than 5 cm.
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I can carry out all my self-care but not work activities.
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I had brain metastasis but finished treatment over 4 weeks ago, am off steroids for 2 weeks, and have no symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post first 6 treatments to 2 years post last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post first 6 treatments to 2 years post last treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Evaluate Durability of Response
Evaluate Local Response Rate (LRR)
Evaluate Objective Response Rate (ORR)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: X-PACT TreatmentExperimental Treatment1 Intervention
Single arm consisting of a six-week treatment period with X-PACT (phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) administered as an intra-tumoral injection. Intra-tumoral injections will be given on D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6. After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart.
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Who is running the clinical trial?
Immunolight, LLCLead Sponsor
William Eward, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't had any cancer treatments in the last 28 days or 5 half-lives, whichever is shorter.I have a history of pancreatitis or high levels of lipase in my blood without a known cause.My tumor can be reached for treatment either directly or with imaging guidance.My side effects from previous treatments are mild or gone.I am a male willing to use condoms during and for 28 days after treatment.I have another cancer besides the one being studied, but it's either not active or is a minor type that doesn't require treatment.My cancer does not involve my eyes or brain.I can understand and follow the study's procedures.The tumor must be able to be measured using specific criteria.My organs are functioning well.My tumor is on the surface and not deeper than 5 cm.My tumor is larger than 500 cc if it's a Soft Tissue Sarcoma, or up to 300 cc for other types.I can carry out all my self-care but not work activities.I do not have serious heart issues or other illnesses that could affect my participation.My radiation oncologist agrees more radiation is safe for me, considering my past treatments.I had radiation over 6 months ago, with no major organ damage or lasting effects.My cancer has grown despite treatment, or I can't undergo standard treatments.I had brain metastasis but finished treatment over 4 weeks ago, am off steroids for 2 weeks, and have no symptoms.80% of my tumor can be reached for treatment with an injection.You have a history of severe reactions to certain medications, light-sensitive diseases, or certain infections like HIV, hepatitis B, or hepatitis C.The tumor chosen for treatment is one where controlling it locally could help me.I am a woman who can have children and have a recent negative pregnancy test.The patient is expected to live for at least 4 months.I have been treated with methoxsalen before.I do not have an active infection needing treatment, or it's a simple UTI.I am using or plan to use corticosteroids, but I can stop them for a week if needed.I haven't taken any experimental drugs in the last 28 days.I am taking 10 mg or more of prednisone or biologic agents for my autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: X-PACT Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants able to join this research initiative?
"According to the information posted on clinicaltrials.gov, this study is actively seeking participants since its inception in December 2021 with a recent update in August 2022."
Answered by AI
Does X-PACT present any risks to those receiving it?
"Based on our assessment, X-PACT is fairly safe with a score of 1 as it has only undergone limited testing for safety and efficacy."
Answered by AI
How many enrollees are being accepted into the experiment?
"Affirmative. The information on clinicaltrials.gov shows that this medical trial is presently looking for volunteers to enrol in the study - which was first published on December 8th 2021 and last modified on August 23rd 2022. To fulfil their requirements, they will need 12 subjects from 2 locations."
Answered by AI
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