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Trial record 22 of 2711 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor

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ClinicalTrials.gov Identifier: NCT03197012
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumor Drug: 90Y-DOTA-TOC Drug: 68Ga-DOTA-TOC Early Phase 1

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 PET/CT and the following day using PET/MRI.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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
Official Title: Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arm Intervention/treatment
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.
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

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

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor 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 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 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. AST (SGOT) / ALT (SGPT) > 3 x 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197012


Contacts
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Contact: Clinical Trials Office - UCSF Cancer Center (877) 827-3222 cancertrials@ucsf.edu
Contact: Bryant Chee 415-353-7145 Bryant.Chee@ucsf.edu

Locations
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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94158
Contact: Clinical Trials Office - UCSF Cancer Center    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Thomas Hope, MD         
Sponsors and Collaborators
Thomas Hope
Investigators
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Principal Investigator: Thomas Hope, MD University of California, San Francisco

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Responsible Party: Thomas Hope, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03197012     History of Changes
Other Study ID Numbers: CC# 17455
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Hope, University of California, San Francisco:
neuroendocrine tumor (NET)
Peptide Receptor Radionuclide Therapy (PRRT)
somatostatin receptor (SSTR)

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Edotreotide
Octreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents