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X-PACT for Advanced Cancers
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: X-PACT Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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