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Trial record 1 of 51 for:    DOTA- | Neuroendocrine Tumors
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Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03197012
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 23, 2017
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
  • Overall Response Rate (ORR) [ Time Frame: Over the duration of the study, which is estimated to be approximately 36 months ]
    Based on change in size of hepatic lesions three and six months after treatment with IA 90Y-DOTA-TOC using RECIST criteria.
  • Incidence of Treatment-Related Adverse Events [Safety] [ Time Frame: Over the duration of the study, which is estimated to be approximately 36 months ]
    Based on laboratory evaluation and CTCAE 4.0 criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03197012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
  • Change in SUVmax between pre-treatment IV 68Ga-DOTA-TOC PET and treatment IA 68Ga-DOTA-TOC. [ Time Frame: Over the duration of the study, which is estimated to be approximately 36 months ]
    Data from patients in the imaging correlate sub-study only
  • Correlation between uptake on IA 68Ga-DOTA-TOC PET/CT compared to 24-hour post-treatment IA 90Y-DOTA-TOC PET/MRI. [ Time Frame: Over the duration of the study, which is estimated to be approximately 36 months ]
    Data from patients in the imaging correlate sub-study only
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
Official Title  ICMJE Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
Brief Summary

This is a prospective, pilot, single center, open-label study in patients with metastatic neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic artery.

Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose, and undergo additional imaging and assessment.

Detailed Description

Prior to the procedure, the patient will be instructed to fast overnight. Upon arrival to the hospital intravenous (IV) access will be placed, and Additionally, a scopolamine patch may be placed the night prior to treatment. Additionally a Foley catheter will be placed.

Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, an amino acid solution will be administered via IV. An angiographic catheter will be directed under fluoroscopic guidance to the appropriate location in the hepatic artery.

The 90Y-DOTA-TOC dose will be administered over thirty minutes via the hepatic arterial catheter in an outpatient setting.

Ten patients also enrolled in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the therapeutic dose and 90 minutes after treatment, these patients will be imaged 90 minutes after treatment using a Positron Emission Tomography (PET) combined with Computerized tomography (CT) (PET/CT) and the following day using ositron Emission Tomography (PET) combined with magnetic resonance imaging (MRI) (PET/MR).

All study participants will be followed up on protocol for six months for evaluation of toxicity and response to treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Main study: All participants will receive a single administration of intra-arterial 90Y-DOTA-TOC.

There will be a sub-study involving 10 patients from the main study who will undergo additionally correlative imaging to compare IA vs IV administration (intra-arterial 68Ga-DOTA-TOC administration and subsequent PET imaging).

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumor
Intervention  ICMJE
  • Drug: 90Y-DOTA-TOC
    Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, amino acid solution will be administered via IV, and will continue through the PRRT procedure. An angiographic catheter will be inserted under fluoroscopic guidance to the appropriate location in the hepatic artery. 90Y-DOTA-TOC will be administered via the hepatic arterial catheter.
    Other Name: Yttrium-90 DOTATOC
  • Drug: 68Ga-DOTA-TOC
    In the sub-study, 10 patients will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose and 90 minutes after treatment, these patients will be imaged using a PET/CT. The following day, patients enrolled in the sub-study will undergo a PET/MRI.
    Other Name: Gallium-68 DOTATOC
Study Arms  ICMJE
  • Experimental: Main Study: 90Y-DOTA-TOC
    90Y-DOTA-TOC will be administered one time over thirty minutes via the hepatic arterial catheter in the outpatient setting. The injected dose will be 85 to 115 mCi.
    Intervention: Drug: 90Y-DOTA-TOC
  • Experimental: Sub-study: 90Y and 68Ga-DOTA-TOC

    90Y-DOTA-TOC will be administered one time over thirty minutes via the hepatic arterial catheter in the outpatient setting. The injected dose will be 85 to 115 mCi.

    Patients enrolled in the correlative sub-study will also receive 111-259 MBq (3-7 mCi) of 68Ga-DOTA-TOC concurrent with 90Y-DOTA-TOC

    Interventions:
    • Drug: 90Y-DOTA-TOC
    • Drug: 68Ga-DOTA-TOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 19, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2017)
32
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor Positron Emission Tomography (PET).

  1. All sites or origin are eligible.
  2. Functional and nonfunctional tumors are allowed. 2. Hepatic metastases on imaging meeting the following criteria:

a. Liver-only or liver-dominant metastases, defined as: i. At least 10% liver parenchyma replacement by tumor, but less than 70% replacement of the hepatic parenchyma by tumor.

1. For the imaging sub-study: at least one liver lesion must measure greater than 2 cm in size 2. For the imaging sub-study: treatment must only be performed using a single dose, and so arterial variant anatomy that would result in a split treatment will not be allowed ii. And, progression of the liver metastases demonstrated within the past twelve months defined as either:

  1. Appearance of any new liver lesion or
  2. 20% increase in size of at least one liver lesion. iii. Presence of low-volume extrahepatic lesions (including primary tumor) is allowed if they are stable and asymptomatic.

    b. SUVmax on 68Ga-DOTA-TOC PET of the liver metastases two times greater than the adjacent liver parenchyma.

  3. Not a candidate for surgical debulking.
  4. ECOG performance status 0, 1 or 2
  5. Age > 18.
  6. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  1. Patients not capable of getting PET study due to weight, claustrophobia, or inability to lie still for the duration of the exam.

    a. For patients in the imaging correlate sub-study: contraindication for undergoing MRI based on University of California, San Francisco (UCSF) Radiology guidelines.

  2. Contraindication to hepatic arteriography (e.g. hepatic artery dissection and/or thrombosis, uncorrectable coagulopathy, severe allergy to iodinated contrast, severe vascular disease precluding safe hepatic artery catheterization).
  3. Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 48 hours before and 24 hours after the administration of 90Y-DOTA-TOC, or any patient receiving treatment with octreotide long-acting release (LAR) or lanreotide, which cannot be interrupted for at least 4 weeks before the administration of 90Y-DOTA-TOC.

    a. Concurrent somatostatin receptor analog (SSA) allowed if progression has been documented and the SSA dose has been stable for at least two months. Long-acting SSA cannot be given within four weeks of treatment and short-acting SSA cannot be given with 48 hours of treatment. SSA therapy can restart one day after treatment.

  4. Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within 4 weeks prior to enrollment. Bevacizumab within 6 weeks prior to enrollment.
  5. Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment.
  6. Any external beam radiation treatment for hepatic disease. Prior external beam radiation therapy to more than 25% of the bone marrow.

    a. Prior systemic PRRT treatment is allowed, if it was performed at least six months prior.

  7. Pregnancy or lactation. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  8. Impaired liver function

    1. aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) / alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) > 3 x upper limit of normal (ULN).
    2. Total bilirubin >1.5 x ULN
    3. Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
    4. Thrombosis of the main portal vein
    5. Clinical evidence of ascites (trace ascites on imaging acceptable).
  9. Impaired bone marrow reserve

    1. Hb concentration < 8.0 g/dL;
    2. Total White Blood Cell count (WBC) <2x109/L (2000/mm3);
    3. Platelets <75x109/L (75x103/mm3).
  10. Creatinine clearance <50 mL/min calculated by the Cockroft Gault method.
  11. Known intracranial metastases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03197012
Other Study ID Numbers  ICMJE 17455
NCI-2017-01886 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Hope, University of California, San Francisco
Study Sponsor  ICMJE Thomas Hope
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Hope, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP