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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 below

Select...

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.

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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.

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I am at risk of falling.

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I have undergone peptide-receptor radiotherapy.

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I have moderate to severe protein in my urine.

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I have had radiation therapy that affected a quarter of my bone marrow.

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I am allergic to certain cancer imaging or treatment drugs.

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I have more than one type of cancer at the same time.

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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

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

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 more

Secondary study objectives

Overall survival (OS)

Progression free survival (PFS)

Side effects data

From 2021 Phase 2 trial • 114 Patients • NCT02035137

92%

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%

10047900-Weight loss

14%

10019211-Headache

14%

10040752-Sinus tachycardia

14%

10001675-Alkaline phosphatase increased

11%

10006504-Bruising

11%

10011368-Creatinine increased

11%

10021097-Hypotension

11%

10021028-Hypomagnesemia

11%

10033371-Pain

10002855-Anxiety

10020772-Hypertension

10013781-Dry mouth

10014383-Electrocardiogram QT corrected interval prolonged

10003988-Back pain

10005364-Blood bilirubin increased

10000081-Abdominal pain

10001760-Alopecia

10014222-Edema face

10000060-Abdominal distension

10041367-Sore throat

10001723-Allergic rhinitis

10033425-Pain in extremity

10012174-Dehydration

10045158-Tumor pain

10025482-Malaise

10034310-Penile pain

10021005-Hypoglycemia

10020647-Hyperkalemia

10028130-Mucositis oral

10021143-Hypoxia

10056910-GGT increased

10001497-Agitation

10020680-Hypernatremia

INFLUENZA A

10038695-Respiratory failure

10016791-Flu like symptoms

10019450-Hematuria

10062501-Non-cardiac chest pain

10007810-Catheter related infection

10008531-Chills

10031009-Oral pain

10041349-Somnolence

10009887-Colitis

10013573-Dizziness

10065776-Muscle weakness lower limb

10046300-Upper respiratory infection

10040047-Sepsis

10065764-Mucosal infection

DISEASE PROGRESSION

MULTIPLE BACTERIAL INFECTIONS (ENTEROBACTER, CITROBACTER, KLEBSIELLA, GPC, GVC)

HYPERPHOSPHATEMIA

10013911-Dysgeusia

10033987-Paresthesia

10037032-Proteinuria

10041232-Sneezing

MURMUR

RIB PAIN

10035598-Pleural effusion

10016059-Facial pain

10046555-Urinary retention

URETHRAL TRAUMA

10054482-Neck edema

DRY CRACKED LIPS

10037868-Rash maculo-papular

10065780-Muscle weakness left-sided

10017577-Gait disturbance

10020587-Hypercalcemia

10050068-Edema limbs

10051792-Infusion related reaction

ENTEROBACTER CLOCACAE

10015090-Epistaxis

10013963-Dyspnea

JAW PAIN

10021114-Hypothyroidism

10025258-Lymphocyte count increased

10049737-Treatment related secondary malignancy

10016825-Flushing

10019245-Hearing impaired

10028836-Neck pain

10061322-Optic nerve disorder

10030980-Oral hemorrhage

10008496-Chest wall pain

10017076-Fracture

RESPIRATORY DEPRESSION FROM SEDATION

100%

80%

60%

40%

20%

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

0 / 21Eligibility criteria met