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Radiopharmaceutical
CLR 131 + Radiation for Head and Neck Cancer
Phase 1
Waitlist Available
Led By Justine Bruce, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have at least one evaluable (measurable or non-measurable) recurrent lesion that is amenable to radiation therapy.
Participants with histologically or cytologically confirmed solid malignancy that has recurred in the head and neck (above the clavicles) region, e.g., participants with recurrent cutaneous squamous cell carcinoma, salivary gland tumors or esthesioneuroblastoma are eligible for this clinical trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights
Study Summary
This trial is testing an investigational drug that selectively delivers radiation to malignant tumor cells, in combination with external beam radiation therapy, in subjects with locoregionally recurrent head and neck cancer. Up to 12 participants who are able to have radiation therapy again may be enrolled. The trial will first establish drug uptake by the tumor with a dose of CLR 131. If there is uptake, the participant will then receive a cumulative tumor dose of 60-70 Gy using the investigational drug combined with external beam radiation.
Who is the study for?
This trial is for adults with head and neck cancer that has come back after treatment, including those with distant metastases if the main concern is the local recurrence. They must have had prior radiation therapy, be in good physical condition (ECOG 0-1), expected to live at least 6 more months, and show CLR 131 uptake in tumors on imaging. Participants need proper blood counts, kidney and liver function, agree to use contraception, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests an experimental drug called CLR 131 combined with external beam radiation therapy (EBRT) on up to 12 patients with recurrent head and neck cancer. The drug delivers targeted radiation to tumor cells. Patients will first receive a test dose of CLR 131 for imaging purposes; if successful uptake by the tumor is confirmed, they'll get a personalized cumulative tumor dose calculated using Monte Carlo methods along with EBRT.See study design
What are the potential side effects?
Potential side effects include reactions related to targeted radiation such as localized swelling or damage where CLR 131 accumulates in the body. There may also be general symptoms like fatigue or nausea from both treatments' impact on healthy tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one cancer lesion that can be treated with radiation.
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My cancer has returned in the head or neck area.
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I have had radiation therapy aiming to cure my condition.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine levels, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Secondary outcome measures
CLR 131 Tumor Uptake via SPECT/CT Imaging
Change in Quality of Life: MDADI Score
Change in Stimulated Salivary Flow
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CLR 131 Dose EscalationExperimental Treatment1 Intervention
Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8.
Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m^2 Dose Level 1 (beginning dose) = 15.6 mCi/m^2 Dose Level 2 (escalation dose) = 18.75 mCi/m^2
Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,375 Total Patients Enrolled
Cellectar Biosciences, Inc.Industry Sponsor
14 Previous Clinical Trials
1,253 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,600 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one cancer lesion that can be treated with radiation.I haven't had cancer (except for certain low-risk types) treated in the last 2 years.I have not had a stroke or mini-stroke in the last year.My tumor is near the spinal cord and might swell with treatment.I have had serious side effects from treatments over 4 weeks ago, but not including hair loss or tiredness.I do not have any severe health or mental conditions that are not under control.I have thyroid cancer.My liver is functioning well.My severe COPD is not well-managed.My kidney function is normal.My cancer has returned in the head or neck area.My thyroid condition is not under control.I have a condition that increases my risk of uncontrolled bleeding.My cancer shows CLR 131 uptake in imaging for the area to be treated, or I am part of a subset allowed to continue treatment without this uptake.I am using or will use effective birth control during and 6 months after the study.I have not had a serious cancer other than my current one in the last 5 years.I agree to use contraception or abstain from sex as required.My recurrent tumor is advised for surgery by a specialized cancer team.My blood thinner medication can be safely stopped if needed.I am not currently receiving any other cancer treatments.I have had radiation therapy aiming to cure my condition.I am on stable low-dose steroids for a rheumatologic condition, not exceeding 10 mg of prednisone daily.I have not had full or half-body radiation or systemic radioisotope therapy, except for benign thyroid disease.I am currently on dialysis.I understand this study is experimental and I can sign the consent form.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread, but treating the cancer in its original location is the priority.I haven't had chemotherapy, major surgery in the last 4 weeks, or radiotherapy in the last 2 weeks.I cannot use a standard IV line due to poor vein access.I haven't had a heart attack or serious heart issues in the last 6 months.My kidney function, measured by creatinine levels, is within the normal range.I do not have any ongoing infections like TB, hepatitis B or C, or HIV.I am on full-dose blood thinners and my platelet count is at least 150,000.
Research Study Groups:
This trial has the following groups:- Group 1: CLR 131 Dose Escalation
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.
Is this a pioneering exploration of its kind?
"Since 2017, CLR 131 has been the focus of 3 active trials across 6 countries and 24 cities. This promising drug initially gained traction after Cellectar Biosciences, Inc. sponsored a study involving 120 patients in 2017 which resulted in its Phase 2 approval."
Answered by AI
Are there any other studies that have investigated the effects of CLR 131?
"Currently, there are three clinical trials evaluating the efficacy of CLR 131, none in Phase 3. These medical studies can be found at 33 different locations across New york City."
Answered by AI
Can CLR 131 be safely administered to individuals without any adverse effects?
"Considering the limited evidence indicating CLR 131's safety and efficacy, its rating on a 1 to 3 scale is set at 1."
Answered by AI
What is the upper limit of participants in this trial?
"At this time, no new patients are being admitted to this study. The medical trial was first listed on December 20th 2019 and most recently updated on July 25th 2022. If individuals with head and neck cancer desire more options, 480 other studies presently accept enrollment while 3 trials still recruit for CLR 131 therapy."
Answered by AI
Are there any active recruitment opportunities for this clinical research?
"This study has already reached its recruitment quota and is no longer seeking enrolment. It was first posted on December 20th 2019, with the last modification to the trial occuring July 25th 2022. If you are still searching for other trials, there are 480 open studies available for head and neck cancer, as well as 3 active clinical trials recruiting participants specifically for CLR 131 treatment."
Answered by AI
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