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Codrituzumab for Solid Tumors
Study Summary
This trial is testing whether codrituzumab is safe and has few side effects in children and young adults with solid tumors that express the protein GPC3.
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 haven't taken high-dose steroids or immunosuppressants for over 14 days.I had my last radiation treatment more than 14, 42, or 120 days ago, depending on the type and dose.My neurological condition has been stable for over a week without steroids, and I can use a wheelchair.My cancer has returned or didn’t respond to treatment and is not in the brain.I have never had GPC3-directed immunotherapy.I haven't taken any medication to boost my blood cells for at least a week.I am between 1 and 21 years old at the time of signing up for the study.I do not have uncontrolled seizures.I have recovered from side effects of my previous cancer treatments.I do not have any infections that are currently uncontrolled.My cancer can be measured by scans.I do not have anti-codrituzumab antibodies.My blood counts and liver/kidney functions are within required ranges for treatment.It's been over 84 days since my allogeneic transplant or over 42 days since my autologous stem cell infusion, and I don't have GvHD.My tumor shows GPC3 protein presence from any past test.I do not have any brain tumors or brain damage.I can do most daily activities by myself.
- Group 1: Codrituzumab
- 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 individuals aged 50 or more being enlisted for this investigation?
"The study requires potential participants to be aged between 1 year old and 21 years. Noteworthy, there are 301 trials that cater to minors while 2194 studies have been designed with seniors in mind."
What is the aggregate population size of individuals participating in this investigation?
"This clinical trial necessitates 50 enrollees that meet the predetermined requirements. Those eligible can take part at either Cincinnati Children's Hospital Medical Center in Ohio or Memorial Sloan Kettering Cancer Centre located in New york City."
What other research initiatives have been conducted surrounding Codrituzumab?
"Currently, there is just one clinical trial of codrituzumab. It has yet to reach Phase 3 and the primary study site is Los Angeles, California although it is also running trials in three other locations."
Who meets the eligibility criteria for participation in this investigation?
"This clinical trial is looking to recruit 50 participants between 1 year and 21 years of age with cancer. To be eligible, the patient must meet certain criteria including being at least 12 months old but younger than 22 on enrollment date; having a diagnosis of relapsed or refractory hepatoblastoma; achieving Karnofsky Performance Score (for patients > 16) or Lansky Performance Score (for patients ≤16) greater than 50% within 2 weeks from enrollment; any tumor that has recurred twice is considered relapsed and any tumor which progresses despite maximal standard therapies is classified as refractory, plus disease must be measurable according to REC"
Is this program the first of its kind to be conducted?
"Presently, Chugai Pharma USA's drug Codrituzumab has a single live trial being conducted over 3 cities in 1 state. In 2021 the first clinical tests were completed and Phase 1 approval was obtained with 50 patients participating. Since then two further experiments have been carried out."
Is this investigation currently accepting enrollees?
"Affirmative, clinicaltrials.gov indicates that this medical investigation is recruiting participants. It was initially announced on June 9th 2021 and amended most recently on October 28th 2022. 50 individuals are required from 3 distinct sites for the study to be successful."
What potential risks could a patient face if they were to be treated with Codrituzumab?
"The limited data that exists suggests Codrituzumab is relatively safe, so it receives a score of 1."
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