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Radioisotope Therapy
Radioligand Therapy for Lung Cancer
Phase < 1
Waitlist Available
Led By Yusuf Menda, MD
Research Sponsored by Yusuf Menda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to provide independent consent
Have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT/CT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment on people who have a specific type of lung cancer. The goal is to see if it is safe.
Who is the study for?
This trial is for patients with atypical carcinoid lung lesions who've tried or declined other treatments. They must have a lesion ≥2 cm that's positive for CXCR4, can consent independently, and have good liver and kidney function. People with recent major surgery, other recent therapies, pregnant or breastfeeding women, those not using birth control, or with uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests a new alpha-radiation treatment called Lead-212 labelled Pentixather on patients who've had previous treatments for lung carcinoid tumors. It also uses Lead-203 Pentixather SPECT/CT imaging to identify suitable lesions before treatment.See study design
What are the potential side effects?
As this is a first-in-human trial of an alpha-radiation therapy, potential side effects may include radiation-related symptoms such as nausea and fatigue; however specific side effects will be monitored closely given the novel nature of the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can make my own medical decisions.
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I have a tumor larger than 2 cm that is positive for CXCR4.
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My liver tests are within the required limits.
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My kidneys work well enough (creatinine clearance ≥ 50 mL/min).
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My initial cancer treatment didn't work or I chose not to continue treatments.
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My blood tests show enough platelets, hemoglobin, and neutrophils.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the recommended phase 2 dose of 212-Lead Pentixather
Secondary outcome measures
Cognitive Therapy
Neoplasms
Trial Design
1Treatment groups
Experimental Treatment
Group I: 212-Lead PentixatherExperimental Treatment2 Interventions
Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints.
Treatment is administered in 2 cycles with 6 weeks between the cycles.
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Who is running the clinical trial?
Yusuf MendaLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,519 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,621 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received antibody therapy in the last 21 days.I haven't had cancer-killing drug treatments in the last 3 weeks.I can make my own medical decisions.I have had a solid organ transplant.My liver tests are within the required limits.I have a tumor larger than 2 cm that is positive for CXCR4.I do not have any severe illnesses that would interfere with the study.I have not had major surgery in the last 4 weeks.My kidneys work well enough (creatinine clearance ≥ 50 mL/min).My initial cancer treatment didn't work or I chose not to continue treatments.I have not had a bone marrow or stem cell transplant in the last 84 days.My blood tests show enough platelets, hemoglobin, and neutrophils.
Research Study Groups:
This trial has the following groups:- Group 1: 212-Lead Pentixather
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 there opportunities to join this medical experiment at the current time?
"clinicaltrials.gov reports that this clinical trial, initially posted on July 1st 2024 and last updated on September 23rd 2022, is no longer looking for candidates to participate in the study. However, there are currently 4004 other studies actively seeking patients."
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