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Radioisotope Therapy
177Lu-DOTA-EB-TATE for Neuroendocrine Cancer
Phase 1
Recruiting
Led By Lisa Bodei, MD, PhD
Research Sponsored by Molecular Targeting Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-17 months
Awards & highlights
Study Summary
This trial is to test a new treatment for a rare cancer. It will study how well the treatment works and what side effects it may have.
Who is the study for?
Adults over 18 with advanced, inoperable well-differentiated neuroendocrine tumors (GEP-NETs) that are positive for somatostatin receptors can join this trial. They must have measurable disease, agree to use contraception, and have not had certain recent treatments or other cancers. People with severe organ dysfunction, active infections like hepatitis or HIV, uncontrolled diabetes, or who are pregnant/breastfeeding cannot participate.Check my eligibility
What is being tested?
The trial is testing the safety and dosage of a new treatment called 177Lu-DOTA-EB-TATE in patients with specific types of neuroendocrine tumors. It's an early-phase study focusing on how well patients tolerate the drug and how it distributes in their bodies.See study design
What are the potential side effects?
Potential side effects may include kidney damage due to radiation exposure from the treatment as well as typical symptoms associated with cancer therapies such as nausea, fatigue, and blood cell count changes. The exact side effects will be monitored closely given this is a Phase I trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16-17 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-17 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.
Secondary outcome measures
To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.
Therapeutic procedure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Peptide Receptor Radionucleotide Therapy (PRRT)Experimental Treatment2 Interventions
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-DOTA-EB-TATE per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 50 mCi to 150 mCi (1.85 -5.55 GBq). Each dose of 177Lu-DOTA-EB-TATE will be administered in association with intravenous renal protective amino acid solutions.
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Who is running the clinical trial?
Molecular Targeting Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
ClinSmartIndustry Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Lisa Bodei, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
10 Patients Enrolled for Neuroendocrine Tumors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used somatostatin or its analogues in the last 4 months.I had local therapy over 4 weeks ago.I have tumors that cannot be treated with local therapies before starting the treatment.I have no other cancers except for possibly non-melanoma skin cancer or treated cervical carcinoma in situ.My bone marrow is not working well.My brain metastases have been treated and are now stable.I cannot stop my octreotide treatment for 24 hours before and after receiving 177Lu-DOTA-EB-TATE.My last surgery was more than 6 weeks ago.I have had more than 4 treatments with 177Lu-DOTA-TATE.I am not pregnant or breastfeeding.I am 18 years old or older.I have severe urinary incontinence making certain cancer treatments unsafe for me.I haven't had cancer treatment or experimental drugs in the last 4 weeks or longer.I am still recovering from a major surgery or injury, or expect to have major surgery soon.My liver is not working well.My kidney function is reduced with a creatinine level over 1.7 mg/dL.I do not have any serious infections like HBV, HCV, HIV, or AIDS.I am able to care for myself but may not be able to do active work.I have not been treated with 177Lu-DOTA-TATE or had no cancer growth for 12 months after treatment.My kidneys are functioning well.My scan shows high levels of certain receptors in at least one cancer lesion.I've had radiation therapy that affected more than a quarter of my bone marrow.Over 80% of my liver is affected by cancer.My tumor is a confirmed, inoperable neuroendocrine tumor of the GI or pancreas.My cancer has spread to over 25% of my bone marrow.My cancer is a type of aggressive neuroendocrine tumor.My side effects from previous treatments have mostly gone away.My neuroendocrine tumor is classified as grade 1, 2, or 3.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Peptide Receptor Radionucleotide Therapy (PRRT)
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.
To what degree is 177Lu-DOTA-EB-TATE hazardous to human health?
"Owing to the data collected during Phase 1, our team at Power has assigned a score of 1 for 177Lu-DOTA-EB-TATE's safety rating. This indicates that there is limited evidence attesting to its efficacy and security."
Answered by AI
How many participants are enrolled in this experimental research?
"Affirmative. According to the information available on clinicaltrials.gov, this medical investigation is actively recruiting patients and has been since its initial posting date of June 18th 2022. 9 applicants are required from 1 location for the successful completion of this trial."
Answered by AI
Are enrollees still being accepted into this research trial?
"Affirmative. According to the information published on clinicaltrials.gov, this trial initially posted on June 18th 2022 is currently recruiting participants. A total of 9 participants need to be enrolled from 1 medical site."
Answered by AI
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