Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02441088 : Theranostics: 68GaDOTATOC and 90YDOTATOC
PhasePhase 2
AgesMin: 6 Months Max: N/A
Eligibility
Inclusion Criteria

1. Disease not amenable to standard treatment (nonresectable or disease present after
one or more surgeries and/or Sandostatin treatment) or subject has failed existing
first line chemotherapy, biologic therapy, targeted agent therapy or radiation
therapy.

2. Participation in Iowa Neuroendocrine Tumor Registry.

3. A pathologically confirmed (histology or cytology) malignant neoplasm with at least
one target lesion that is confirmed by conventional imaging and is determined to
express somatostatin receptors by 68Ga-DOTATOC (TATE) PET within 120 days prior to
treatment with 90Y-DOTATOC.

4. The target lesion is one that either has never received external beam radiation
irradiated or has been previously irradiated and has since demonstrated progression.
Any local irradiation of the target lesion or any non-target lesions via external
beam, conformal or stereotactic radiation treatments must have occurred more than 4
weeks prior to study drug administration. Any full craniospinal radiation, whether or
not a target lesion is included in the field, must have occurred more than 3 months
prior to study drug administration.

5. Life expectancy > /= 2 months at the time of study drug administration.

6. Neuroendocrine archival tissue from a previous biopsy will be required.

7. Age ? 6 months-100 years at the time of study drug administration.

8. Performance status as determined by Karnofsky ? 60% or Lansky Play Scale ? 60% at the
time of study drug administration.

9. Completion of Norfolk Quality of Life Questionnaire.

10. Within 7±10 days of study drug administration, patients must have normal organ and
marrow function as defined below:

- absolute neutrophil count >1000/mm3

- platelets >90,000/mm3

- total bilirubin <3X ULN for age

- AST(SGOT) & ALT(SGPT) <10X institutional upper limit of normal for age

- urinalysis with no greater than 1+ hematuria or proteinuria

- Renal function* Adults (age 18 or >): Serum creatinine ? 1.2 mg/dl; if serum
creatinine is >1.2 mg/dL, nuclear GFR will be measured. GFR will need to be ? 80
ml/min/1.73m2 for subjects ?40 years old, ? 70 ml/min/1.73m2 for subjects between
41-50; ? 60 ml/min/1.73m2 for subjects between 51-60; ? 50 ml/min/1.73m2 for subjects
> 60 years old.

Children (age < 18): nuclear GFR ? 80 mL/min/1.73 m2

* Renal function criteria based on our previous experience with 90Y-DOTATOC therapy
and known changes in GFR with age

11. The effects of 90Y-DOTA-tyr3-Octreotide on the developing human fetus are unknown.
For this reason and because Class C agents are known to be teratogenic, women and men
of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

12. Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria

1. Pregnant women are excluded from this study because 90Y-DOTATOC is a Class C agent
with potential teratogenic or abortifacient effects.

2. Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with 90Y-DOTATOC, breastfeeding should be
discontinued until 6 weeks after the last administration of study drug.

3. Surgery within 4 weeks of study drug administration.

4. External beam radiation to both kidneys (scatter doses of <500 cGy to a single kidney
or radiation to < 50% of a single kidney is acceptable).

5. Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG therapy for
this malignancy.

6. Another investigational drug within 4 weeks of study drug administration.

7. Concurrent, malignant disease for which patient is on active therapy.

8. Another significant medical, psychiatric, or surgical condition which is currently
uncontrolled by treatment and which would likely affect the subject's ability to
complete this protocol.

9. Any subject for whom, in the opinion of their physician, a 12-hour discontinuation of
somatostatin analogue therapy represents a health risk. Also subjects who have
received long-acting somatostatin analogue in the past 28 days or long-acting
lanreotide within the past 16 weeks are excluded. Subjects may be maintained on short
acting octreotide during the time from last injection of long-acting somatostatin
analogue until 12 hrs prior to injection of study drug. Known antibodies to
Octreotide, Lanreotide, or DOTATOC or history of allergic reactions attributed to
compounds of similar chemical or biologic composition to 90Y-DOTATOC.

10. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or
mitomycin C) of study drug administration or those who have not recovered from
adverse events due to agents administered more than 4 weeks earlier.

11. Uncontrolled 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.

12. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will
not be able to fit inside the imaging machines).

13. Inability to lie still for the entire imaging time (due to cough, severe arthritis,
etc.).
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02441088      |      Link to official Clinicaltrials.gov listing
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