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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I have a tumor larger than 1.5 cm that can be measured on scans.
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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.
Select...
My tumor shows positive for specific protein markers or had a positive scan showing these markers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Secondary outcome measures
Overall survival (OS)
Progression free survival (PFS)

Side effects data

From 2021 Phase 2 trial • 114 Patients • NCT02035137
92%
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%
HYPERPHOSPHATEMIA
3%
10040741-Sinus bradycardia
3%
10056910-GGT increased
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
76 Total Patients Enrolled
3 Trials studying Neuroendocrine Tumors
76 Patients Enrolled for Neuroendocrine Tumors
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,568 Total Patients Enrolled
7 Trials studying Neuroendocrine Tumors
182 Patients Enrolled for Neuroendocrine Tumors

Media Library

131I-MIBG (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03044977 — Phase < 1
Neuroendocrine Tumors Research Study Groups: Cohort 2.2 (bone marrow alternative), Cohort 3.1 (renal alternative), Cohort 3, Cohort -1 (alternative cohort), Cohort 2.1 (renal alternative), Cohort 3.2 (bone marrow alternative), Cohort 1, Cohort 2
Neuroendocrine Tumors Clinical Trial 2023: 131I-MIBG Highlights & Side Effects. Trial Name: NCT03044977 — Phase < 1
131I-MIBG (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03044977 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which demographic is enrollment to this trial open?

"This medical study is currently seeking 20 individuals who have a malignant neuroendocrine tumor and are aged between 18 to 80 years old."

Answered by AI

Does your research encompass individuals aged 55 years and beyond?

"This clinical trial is seeking participants aged 18 and over, yet younger than 80."

Answered by AI

Is enrollment for this experiment still available?

"Unfortunately, the trial's last update on August 12th 2022 suggests that this clinical study is not presently in search of candidates. However, there are still 2494 other studies looking for participants today."

Answered by AI
~4 spots leftby Dec 2025