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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
No Placebo-Only Group
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
absolute neutrophil count decreased
glomular filtration rate (eGFR)
platelet count decreased
+1 moreSecondary study objectives
Overall survival (OS)
Progression free survival (PFS)
Side effects data
From 2021 Phase 2 trial • 114 Patients • NCT0203513792%
10035528-Platelet count decreased
86%
10002272-Anemia
84%
10029366-Neutrophil count decreased
81%
10049182-White blood cell decreased
76%
10025256-Lymphocyte count decreased
57%
10003481-Aspartate aminotransferase increased
54%
10047700-Vomiting
46%
10001551-Alanine aminotransferase increased
43%
10000636-Activated partial thromboplastin time prolonged
38%
10002646-Anorexia
35%
10021038-Hyponatremia
35%
10028813-Nausea
32%
10016256-Fatigue
30%
10020943-Hypoalbuminemia
30%
10011224-Cough
27%
10016558-Fever
27%
10020639-Hyperglycemia
27%
10021018-Hypokalemia
22%
10012727-Diarrhea
22%
10020949-Hypocalcemia
22%
10021059-Hypophosphatemia
19%
10010774-Constipation
19%
10020670-Hypermagnesemia
16%
10022402-INR increased
16%
10028735-Nasal congestion
14%
10019211-Headache
14%
10047900-Weight loss
14%
10040752-Sinus tachycardia
14%
10001675-Alkaline phosphatase increased
11%
10006504-Bruising
11%
10011368-Creatinine increased
11%
10021097-Hypotension
11%
10033371-Pain
11%
10021028-Hypomagnesemia
8%
10002855-Anxiety
8%
10020772-Hypertension
8%
10013781-Dry mouth
8%
10014383-Electrocardiogram QT corrected interval prolonged
8%
10003988-Back pain
8%
10005364-Blood bilirubin increased
5%
10000081-Abdominal pain
5%
10001760-Alopecia
5%
10014222-Edema face
5%
10000060-Abdominal distension
5%
10041367-Sore throat
5%
10034310-Penile pain
5%
10001723-Allergic rhinitis
5%
10033425-Pain in extremity
5%
10012174-Dehydration
5%
10045158-Tumor pain
5%
10025482-Malaise
5%
10021005-Hypoglycemia
5%
10020647-Hyperkalemia
5%
10028130-Mucositis oral
5%
10021143-Hypoxia
5%
10056910-GGT increased
5%
10001497-Agitation
5%
10020680-Hypernatremia
3%
INFLUENZA A
3%
10038695-Respiratory failure
3%
10016791-Flu like symptoms
3%
10019450-Hematuria
3%
10062501-Non-cardiac chest pain
3%
10008531-Chills
3%
10031009-Oral pain
3%
10041349-Somnolence
3%
10009887-Colitis
3%
10065776-Muscle weakness lower limb
3%
10007810-Catheter related infection
3%
10046300-Upper respiratory infection
3%
10040047-Sepsis
3%
10065764-Mucosal infection
3%
DISEASE PROGRESSION
3%
10013573-Dizziness
3%
10013911-Dysgeusia
3%
10033987-Paresthesia
3%
10037032-Proteinuria
3%
10041232-Sneezing
3%
HYPERPHOSPHATEMIA
3%
MURMUR
3%
RIB PAIN
3%
10035598-Pleural effusion
3%
10016059-Facial pain
3%
MULTIPLE BACTERIAL INFECTIONS (ENTEROBACTER, CITROBACTER, KLEBSIELLA, GPC, GVC)
3%
10046555-Urinary retention
3%
URETHRAL TRAUMA
3%
10054482-Neck edema
3%
DRY CRACKED LIPS
3%
10037868-Rash maculo-papular
3%
10065780-Muscle weakness left-sided
3%
10017577-Gait disturbance
3%
10020587-Hypercalcemia
3%
10050068-Edema limbs
3%
10051792-Infusion related reaction
3%
ENTEROBACTER CLOCACAE
3%
10015090-Epistaxis
3%
10013963-Dyspnea
3%
JAW PAIN
3%
10021114-Hypothyroidism
3%
10025258-Lymphocyte count increased
3%
10049737-Treatment related secondary malignancy
3%
10016825-Flushing
3%
10019245-Hearing impaired
3%
10028836-Neck pain
3%
10061322-Optic nerve disorder
3%
10030980-Oral hemorrhage
3%
10008496-Chest wall pain
3%
10017076-Fracture
3%
RESPIRATORY DEPRESSION FROM SEDATION
100%
80%
60%
40%
20%
0%
Study treatment Arm
131I-MIBG With Vorinostat
Single-Agent 131I-MIBG
131I-MIBG With Vincristine/Irinotecan
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
747 Total Patients Enrolled
David BushnellLead Sponsor
3 Previous Clinical Trials
26 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,612 Total Patients Enrolled
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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