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Radioactive Drug
Radionuclide Therapies for Neuroendocrine Tumors
Phase < 1
Waitlist Available
Research Sponsored by David Bushnell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥1 evaluable site of disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST
Disease not amenable to curative intent treatment (primarily surgery) and in addition has shown either clinical or radiographic progression on all available (non-radionuclidic) therapies known to confer clinical benefit.
Must not have
Women who are pregnant or breast feeding.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing different doses of two radioactive drugs (131I-MIBG and 90Y-DOTATOC) to see which is best tolerated when given together to treat neuroendocrine tumors in the midgut.
Who is the study for?
This trial is for adults aged 18-70 with midgut neuroendocrine tumors that can't be surgically removed and have worsened despite treatment. They must have certain levels of blood cells, liver function, kidney function, and a tumor visible on scans. Pregnant or breastfeeding women, those at fall risk, with heart failure or other serious health issues are excluded.
What is being tested?
The study tests combining two radioactive drugs (131I-MIBG and 90Y-DOTATOC) to find the safest doses for treating midgut neuroendocrine tumors. These therapies target tumor cells with radiation from within the body.
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, kidney damage, and allergic reactions specific to the radioactive materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor larger than 1.5 cm that can be measured on scans.
Select...
My condition cannot be cured with surgery and has worsened despite all known treatments.
Select...
I have tumors that are both MIBG+ and DOTATOC+.
Select...
My tumor can be treated more effectively with a combination of specific radiation therapies than with one alone.
Select...
My organ and bone marrow function is normal before starting the study drug.
Select...
I am mostly able to care for myself but may not be able to do active work.
Select...
My cancer is a grade 1 or 2 neuroendocrine tumor, likely from the midgut, pheochromocytoma, or paraganglioma.
Select...
My bilirubin levels are within the normal range for my age and weight.
Select...
I am between 18 and 70 years old.
Select...
I can understand and agree to participate in the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Select...
I do not have any serious illnesses that would stop me from following the study's requirements.
Select...
I cannot stop taking medications that affect MIBG scans.
Select...
I am at risk of falling.
Select...
I have undergone peptide-receptor radiotherapy.
Select...
I have moderate to severe protein in my urine.
Select...
I have had radiation therapy that affected a quarter of my bone marrow.
Select...
I am allergic to certain cancer imaging or treatment drugs.
Select...
I have more than one type of cancer at the same time.
Select...
I haven't taken any experimental drugs in the last 4 weeks.
Select...
I have a history of heart failure and my heart's pumping ability is reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
absolute neutrophil count decreased
glomular filtration rate (eGFR)
platelet count decreased
+1 moreSecondary outcome measures
Overall survival (OS)
Progression free survival (PFS)
Side effects data
From 2021 Phase 2 trial • 114 Patients • NCT0203513792%
10035528-Platelet count decreased
89%
10002272-Anemia
89%
10029366-Neutrophil count decreased
84%
10049182-White blood cell decreased
71%
10025256-Lymphocyte count decreased
61%
10003481-Aspartate aminotransferase increased
55%
10001551-Alanine aminotransferase increased
39%
10047700-Vomiting
37%
10021038-Hyponatremia
37%
10028813-Nausea
32%
10011224-Cough
29%
10016256-Fatigue
26%
10002646-Anorexia
26%
10016558-Fever
21%
10021018-Hypokalemia
21%
10020943-Hypoalbuminemia
21%
10020949-Hypocalcemia
18%
10001675-Alkaline phosphatase increased
18%
10021059-Hypophosphatemia
18%
10000081-Abdominal pain
18%
10010774-Constipation
18%
10019211-Headache
18%
10020639-Hyperglycemia
18%
10021028-Hypomagnesemia
16%
10020670-Hypermagnesemia
13%
10006002-Bone pain
13%
10028735-Nasal congestion
11%
10012727-Diarrhea
11%
10001723-Allergic rhinitis
11%
10040752-Sinus tachycardia
11%
10041367-Sore throat
8%
10006504-Bruising
8%
10033425-Pain in extremity
8%
10000636-Activated partial thromboplastin time prolonged
8%
10003988-Back pain
8%
10005364-Blood bilirubin increased
8%
10013786-Dry skin
8%
10020772-Hypertension
8%
10028836-Neck pain
8%
10046571-Urinary tract infection
5%
10002855-Anxiety
5%
10015090-Epistaxis
5%
10025482-Malaise
5%
10034960-Photophobia
5%
10016288-Febrile neutropenia
5%
10007810-Catheter related infection
5%
10013781-Dry mouth
5%
10013963-Dyspnea
5%
10014222-Edema face
5%
10019450-Hematuria
5%
10020587-Hypercalcemia
5%
10020647-Hyperkalemia
5%
10022402-INR increased
5%
10031009-Oral pain
5%
10033371-Pain
5%
10034310-Penile pain
5%
10037087-Pruritus
5%
10062225-Urinary tract pain
3%
10056910-GGT increased
3%
HYPERPHOSPHATEMIA
3%
10040741-Sinus bradycardia
3%
PAIN, LEG
3%
10046300-Upper respiratory infection
3%
10016778-Floaters
3%
10016791-Flu like symptoms
3%
10059827-Rhinitis infective
3%
10050068-Edema limbs
3%
10062466-Localized edema
3%
10066874-Gastroesophageal reflux disease
3%
ADJUSTMENT DISORDER
3%
CONCERN FOR DISEASE PROGRESSION AS INDICATED BY INTERVAL INCREASE IN THE SIZE OF HER OCCIPITAL MASS
3%
DYSURIA
3%
PAPULOERYTHEMATOUS LESIONS - LEFT CHEEK
3%
10002167-Anal pain
3%
10045158-Tumor pain
3%
10048994-Bladder spasm
3%
10021143-Hypoxia
3%
10013573-Dizziness
3%
10013946-Dyspepsia
3%
10015958-Eye pain
3%
10034620-Peripheral sensory neuropathy
3%
10000060-Abdominal distension
3%
INJURY TO LEFT WRIST
3%
10035598-Pleural effusion
3%
RHINORRHEA
3%
PILONIDAL CYST
3%
10005886-Blurred vision
3%
10007839-CD4 lymphocytes decreased
3%
10011368-Creatinine increased
3%
10014020-Ear pain
3%
10020039-Hiccups
3%
10020680-Hypernatremia
3%
10020870-Hypertriglyceridemia
3%
10021005-Hypoglycemia
3%
10021097-Hypotension
3%
10021114-Hypothyroidism
3%
10022437-Insomnia
3%
10022998-Irritability
3%
10024264-Lethargy
3%
10028130-Mucositis oral
3%
10037868-Rash maculo-papular
3%
10038064-Rectal hemorrhage
3%
10040872-Skin infection
3%
10044055-Toothache
3%
10047900-Weight loss
3%
10051792-Infusion related reaction
3%
10065973-Iron overload
3%
ENTEROBACTER CLOACAE
3%
PARAPHIMOSIS
3%
PAROTIDITIS
3%
RHINOVIRUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single-Agent 131I-MIBG
131I-MIBG With Vincristine/Irinotecan
131I-MIBG With Vorinostat
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 3.2 (bone marrow alternative)Experimental Treatment2 Interventions
This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 2.
131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 150 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)
No further dose evaluations are done after this cohort is completed.
Group II: Cohort 3.1 (renal alternative)Experimental Treatment2 Interventions
This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 3.
131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 250 centiGray (cGy) Radiation exposure to the kidneys is limited to 1900 centiGray (cGy)
No further dose evaluations are done after this cohort is completed.
Group III: Cohort 3Experimental Treatment2 Interventions
This treatment arm is opened if Cohort 2 is successful. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 250 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)
Group IV: Cohort 2.2 (bone marrow alternative)Experimental Treatment2 Interventions
This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 2.
131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 100 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)
No further dose evaluations are done after this cohort is completed.
Group V: Cohort 2.1 (renal alternative)Experimental Treatment2 Interventions
This treatment arm is opened if the kidney radiation exposure was not tolerated in cohort 2.
131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 200 centiGray (cGy) Radiation exposure to the kidneys is limited to 1500 centiGray (cGy)
No further dose evaluations are done after this cohort is completed.
Group VI: Cohort 2Experimental Treatment2 Interventions
This treatment arm is opened if Cohort 1 is successful. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 200 centiGray (cGy) Radiation exposure to the kidneys is limited to 2300 centiGray (cGy)
Group VII: Cohort 1Experimental Treatment2 Interventions
This is the initial treatment arm. 131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 150 centiGray (cGy) Radiation exposure to the kidneys is limited to 1900 centiGray (cGy)
Group VIII: Cohort -1 (alternative cohort)Experimental Treatment2 Interventions
This treatment arm is opened if Cohort 1 is not tolerated.
131I-MIBG and 90Y-DOTATOC are administered once per cycle, for up to 2 cycles 12 weeks apart.
Radiation exposure to the bone marrow is limited to 100 centiGray (cGy) Radiation exposure to the kidneys is limited to 1500 centiGray (cGy)
No further dose evaluations are done after this cohort is completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
131I-MIBG
2005
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
757 Total Patients Enrolled
5 Trials studying Neuroendocrine Tumors
97 Patients Enrolled for Neuroendocrine Tumors
David BushnellLead Sponsor
3 Previous Clinical Trials
26 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
26 Patients Enrolled for Neuroendocrine Tumors
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,930 Total Patients Enrolled
7 Trials studying Neuroendocrine Tumors
132 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation that affected my kidneys, but it was limited.To participate, you need to meet at least one of the following requirements:I have tumors that are both MIBG+ and DOTATOC+.My tumor can be treated more effectively with a combination of specific radiation therapies than with one alone.My organ and bone marrow function is normal before starting the study drug.I have not taken long-acting somatostatin analogues in the last 14 days.My condition cannot be cured with surgery and has worsened despite all known treatments.I have a tumor larger than 1.5 cm that can be measured on scans.I am not pregnant or breastfeeding.I do not have any serious illnesses that would stop me from following the study's requirements.I cannot stop taking medications that affect MIBG scans.I am mostly able to care for myself but may not be able to do active work.My cancer is a grade 1 or 2 neuroendocrine tumor, likely from the midgut, pheochromocytoma, or paraganglioma.My bilirubin levels are within the normal range for my age and weight.I am between 18 and 70 years old.I am at risk of falling.I have undergone peptide-receptor radiotherapy.I have moderate to severe protein in my urine.I have had radiation therapy that affected a quarter of my bone marrow.I am allergic to certain cancer imaging or treatment drugs.I have more than one type of cancer at the same time.I can understand and agree to participate in the study.I haven't taken any experimental drugs in the last 4 weeks.You agree to use birth control during the study.I have a history of heart failure and my heart's pumping ability is reduced.I haven't had surgery, radiation, or chemotherapy in the last 4 weeks.My tumor shows positive for specific protein markers or had a positive scan showing these markers.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2.2 (bone marrow alternative)
- Group 2: Cohort 3.1 (renal alternative)
- Group 3: Cohort 3
- Group 4: Cohort -1 (alternative cohort)
- Group 5: Cohort 2.1 (renal alternative)
- Group 6: Cohort 3.2 (bone marrow alternative)
- Group 7: Cohort 1
- Group 8: Cohort 2
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.
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