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Radioisotope Therapy
Lutathera for Neuroendocrine Tumors
Phase < 1
Recruiting
Led By Lisa Bodei, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization
Subjects affected by histologically proven, somatostatin-receptor positive, progressive, nonresectable, liver-dominant metastatic GEP, bronchial or unknown primary tumors, G1, G2 and G3, according to the new WHO classification of 2017
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test whether it's safe & effective to give Lutathera directly into the liver artery, compared to the standard approach of intravenous infusion in the arm.
Who is the study for?
This trial is for adults with certain types of neuroendocrine tumors that have spread to the liver and are not suitable for surgery. Participants must have a positive somatostatin-receptor, measurable disease progression, and be in relatively good health with an ECOG performance status of 0 or 1. They should agree to use contraception and can't join if they've had certain prior treatments like radiolabeled somatostatin analogs or extensive chemotherapy.Check my eligibility
What is being tested?
The study tests Lutathera (177Lu-DOTATATE) delivered directly into the liver's artery versus standard intravenous infusion. It aims to determine which method is safer, more practical, and effective against cancer by comparing their effects on tumor growth.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, abdominal pain due to radiation exposure; fatigue; blood cell count changes leading to increased infection risk; kidney damage; and possible allergic reactions related to the drug components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of NET that cannot be surgically removed and mainly affects my liver.
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My tumor is a type that grows in the digestive or respiratory system and cannot be surgically removed, but it responds to a specific hormone therapy.
Select...
My tumor is a type that grows in the digestive or respiratory system and cannot be surgically removed, but it responds to a specific hormone therapy.
Select...
I am fully active or able to carry out light work.
Select...
My tumor is a certain type of neuroendocrine tumor, as classified by specific medical standards.
Select...
My cancer has grown by at least 20%.
Select...
My scan shows high levels of certain receptors in at least one cancer spot.
Select...
I am experiencing symptoms due to my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response
number of patients who successfully complete 2 IA injections
Side effects data
From 2021 Phase 3 trial • 231 Patients • NCT0157823927%
Fatigue
19%
Abdominal pain
18%
Diarrhoea
13%
Abdominal distension
12%
Nausea
11%
Decreased appetite
10%
Arthralgia
10%
Back pain
9%
Hyperglycaemia
9%
Hypokalaemia
9%
Flushing
9%
Oedema peripheral
9%
Dizziness
8%
Dyspnoea
8%
Vomiting
8%
Gamma-glutamyltransferase increased
7%
Hypertension
7%
Weight decreased
7%
Aspartate aminotransferase increased
7%
Insomnia
7%
Anaemia
7%
Blood alkaline phosphatase increased
7%
Cough
7%
Asthenia
6%
Urinary tract infection
6%
Alanine aminotransferase increased
6%
Dyspepsia
5%
Anxiety
5%
Palpitations
5%
Constipation
5%
Flatulence
5%
Blood creatinine increased
5%
Musculoskeletal pain
5%
Pain in extremity
5%
Headache
4%
Hyponatraemia
4%
Malignant neoplasm progression
4%
Influenza like illness
3%
Haematuria
3%
Pyrexia
3%
Blood bilirubin increased
2%
Syncope
2%
Lymphocyte count decreased
2%
Platelet count decreased
2%
Abdominal pain lower
2%
General physical health deterioration
2%
Abdominal pain upper
2%
Alopecia
2%
Small intestinal obstruction
2%
Muscle spasms
2%
Dysgeusia
1%
Neoplasm progression
1%
White blood cell count decreased
1%
Breast cancer stage I
1%
Thrombotic cerebral infarction
1%
Carcinoid crisis
1%
Non-small cell lung cancer
1%
Hyperuricaemia
1%
Haemorrhage intracranial
1%
Pleural effusion
1%
Arteriospasm coronary
1%
Cardiac failure congestive
1%
Duodenal obstruction
1%
Gastrointestinal obstruction
1%
Ileus
1%
Impaired gastric emptying
1%
Generalised oedema
1%
Limb injury
1%
Muscular weakness
1%
Prostate cancer
1%
Transient global amnesia
1%
Acute kidney injury
1%
Renal impairment
1%
Cholecystitis acute
1%
Anal haemorrhage
1%
Ascites
1%
Dehydration
1%
Basal cell carcinoma
1%
Malignant bowel obstruction
1%
Oesophagitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide LAR
177Lu-DOTA0-Tyr3-Octreotate
Trial Design
1Treatment groups
Experimental Treatment
Group I: PRRT with 177Lu-DOTATATEExperimental Treatment1 Intervention
Patients will undergo a routine 68Ga-DOTATATE PET/CT. Patients with sufficient tumor uptake will be offered therapy with 177Lu-DOTATATE. The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
177Lu-DOTATATE
2010
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,879 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
461 Patients Enrolled for Neuroendocrine Tumors
Lisa Bodei, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
9 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo surgery to cure my condition, but past surgeries are okay if they were over 6 weeks ago.A disease that can be measured using the RECIST 1.1 guidelines, with at least one dimension measuring 1.0 cm or more.Any new skin lesion that appears should be evaluated by a healthcare professional.My kidney function is poor, with high creatinine or low filtration rate.I have severe urinary incontinence that makes certain cancer treatments unsafe.My liver is mostly affected by cancer, as confirmed by a radiologist.My side effects from previous treatments have not fully improved.I have had chemotherapy, but not capecitabine + temozolomide pills.My cancer is a type of NET that cannot be surgically removed and mainly affects my liver.I have had liver radioembolization treatment with 90Y-microspheres.My cancer has worsened or spread in the last 6 months.My liver isn't working well (high INR, PTT, bilirubin or low albumin).My diabetes is not well-managed.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have no other cancers except for treated skin cancer or cervical carcinoma in situ.My tumor is a type that grows in the digestive or respiratory system and cannot be surgically removed, but it responds to a specific hormone therapy.My tumor is a type that grows in the digestive or respiratory system and cannot be surgically removed, but it responds to a specific hormone therapy.I finished any previous cancer treatments over 4 weeks ago and my cancer has grown since then.I am fully active or able to carry out light work.My tumor is a certain type of neuroendocrine tumor, as classified by specific medical standards.My blood tests show low levels of hemoglobin, white cells, and platelets.I agree to use birth control during the study.My cancer is a type of aggressive neuroendocrine tumor.I cannot have certain imaging tests due to allergies, kidney issues, or other reasons.I have been treated with radiolabeled somatostatin analogs before.are required for all research
All research projects require the participant to be able to understand the consent document and be willing to sign it.My brain metastases have been treated and are now stable.I cannot stop my short-acting Octreotide treatment for 48 hours or schedule it 4 weeks apart from 177Lu-DOTATATE.I am not pregnant or breastfeeding.My cancer has grown by at least 20%.My scan shows high levels of certain receptors in at least one cancer spot.I had local therapy over 6 weeks ago and my cancer has grown since then.You have had allergic reactions to similar drugs like 177Lu-DOTATATE in the past, according to your medical records.I have had radiation therapy that affected more than a quarter of my bone marrow.I am experiencing symptoms due to my cancer.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PRRT with 177Lu-DOTATATE
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 any vacancies available for this research endeavor?
"According to the clinicaltrials.gov database, this research effort is presently open for participants and was first announced on September 2nd 2020 with its latest update being January 19th 2022."
Answered by AI
How many candidates does this trial have capacity for?
"Affirmative, the information hosted on clinicaltrials.gov elucidates that this study is currently recruiting participants; being originally posted on September 2nd 2020 and recently updated on January 19th 2022. A total of 10 enrollees are sought across a single site."
Answered by AI
Could you provide a summary of prior research undertaken into the efficacy of 177Lu-DOTATATE?
"Currently, 23 active clinical trials are assessing the efficacy of 177Lu-DOTATATE, with one in its final phase. This treatment is being studied by researchers across 162 sites, particularly concentrated in Québec and Iowa."
Answered by AI
Who else is applying?
What state do they live in?
Idaho
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
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