Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

NCT03273712 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 201708778R01CA167632201412770
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.

Conditions

Neuroendocrine Tumors; Meningioma; Neuroblastoma; Medulloblastoma

Outcome Measures

Primary Outcomes (3)

• Frequency of Tumor Response at 9 Months After Last Treatment

  Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.

  Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.

• Percentage of Patients With Grade 4 or Higher Renal Adverse Event.

  The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.

  Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.

• Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events

  The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.

  Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.

Study Arms (1)

90Y-DOTA-tyr3-Octreotide

EXPERIMENTAL

Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.

Radiation: 90Y-DOTA tyr3-Octreotide; Diagnostic Test: 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan; Drug: Amino Acids

Interventions

90Y-DOTA tyr3-Octreotide RADIATION

90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.

Also known as: 90Y-DOTATOC

90Y-DOTA-tyr3-Octreotide

68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan DIAGNOSTIC_TEST

68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.

90Y-DOTA-tyr3-Octreotide

Amino Acids DRUG

This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.

Also known as: Lysine and Arginine

90Y-DOTA-tyr3-Octreotide

Eligibility Criteria

• Age: 6 Months - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participation in Iowa Neuroendocrine Tumor Registry.
• 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 6 months prior to treatment with 90Y-DOTATOC.
• The target lesion is one that either has never received external beam radiation 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 cranial-spinal radiation, whether or not a target lesion is included in the field, must have occurred more than 3 months prior to study drug administration.
• Life expectancy \> 2 months at the time of study drug administration.
• Archival tissue from a previous biopsy will be required.
• Age ≥ 6 months-90 years at the time of study drug administration.
• Performance status as determined by Karnofsky ≥ 60 or Lansky Play Scale ≥ 60% at the time of study drug administration.
• Completion of Norfolk Quality of Life Questionnaire.
• 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 no greater than 1+ hematuria or proteinuria

You may not qualify if:

• Pregnant women are excluded from this study because 90Y-DOTATOC is a Class C agent with potential teratogenic or abortifacient effects.
• 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.
• Surgery within 4 weeks of study drug administration.
• 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).
• Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG therapy for this malignancy.
• Another investigational drug within 4 weeks of study drug administration.
• Concurrent, malignant disease for which patient is on active therapy.
• 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.
• 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 SandostatinLAR in the past 28 days or long-acting lanreotide within the past 8 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.
• 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.
• 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.
• Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines.)
• Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)

Sponsors & Collaborators

• University of Iowa: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Meningioma; Neuroblastoma; Medulloblastoma

Interventions

90Y-octreotide, DOTA-Tyr(3)-; Whole Body Imaging; Amino Acids; arginyllysine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Glioma

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: M. Sue O'Dorisio, MD, PhD
• Organization: University of Iowa

sue-odorisio@uiowa.edu

(319) 335-7234

Study Officials

• M. Sue O'Dorisio, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 6, 2017
• Study Start: September 29, 2017
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: February 9, 2023
• Results First Posted: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)