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Combination Targeted Radiotherapy in Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT01099228
Recruitment Status : Completed
First Posted : April 6, 2010
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
David Bushnell, University of Iowa

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE April 6, 2010
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2010)
Dosimetry Results [ Time Frame: 1 week after scan ]
Determine the patient specific bone marrow, kidney and tumor dosimetry results for each subject from the 2 groups will be used to calculate the optimal combination of administered activities for 131I-MIBG plus 90Y-DOTATOC (group 1) 131I-MIBG plus 177Lu-DOTATATE (group 2) and the resultant dose delivery to tumor from each combination
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01099228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2010)
Maximum Radiation Dose [ Time Frame: 3 months ]
Calculate the optimal amount for either agent when administered individually along with corresponding tumor radiation dose to determine the amount of each product will give maximum tumor kill and not damage other vunerable organs..
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 Combination Targeted Radiotherapy in Neuroendocrine Tumors
Official Title  ICMJE Combination Targeted Radiotherapy in Neuroendocrine Tumors
Brief Summary The primary aim of this project is to determine, what fraction of individuals with neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent therapy compared to "best" single agent therapy and determine the magnitude of the potential tumor radiation dose increase.
Detailed Description

RESEARCH PLAN / BACKGROUND AND SIGNIFICANCE:

Tumors originating from the neuroendocrine system, although relatively rare, may be life threatening. In cases where the disease has metastasized, the 5 year survival is very poor. 131I meta-iodobenzylguanidine (MIBG)and 90Y DOTA-D-Phe1-Tyr3-Octreotide (DOTATOC) are two radiopharmaceuticals that have shown promise as therapeutic agents in patients with metastatic neuroendocrine tumors. However, delivering sufficient radiation dose to the tumor to obtain objective anti-tumor responses or cure with these radiopharmaceuticals is challenging because of the allowable dose limits imposed by radiation damage to normal tissues. Organ biodistribution and kinetics of 90Y DOTATOC and 131I MIBG are substantially different, which leads to different critical organs for these agents, the kidney for Y90Y DOTATOC and the red marrow for 131I MIBG. We propose to investigate a mechanism to increase the radiation dose delivered to tumors without exceeding "critical" radiation dose to normal organs by combining 90Y DOTATOC and 131I MIBG.

AIMS / OBJECTIVES:

The primary aim of this project is to determine, what fraction of individuals with neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent therapy compared to "best" single agent therapy and determine the magnitude of the potential tumor radiation dose increase.

METHODS:

To achieve this, we plan to perform serial scintigraphic imaging procedures to measure patient specific bone marrow, kidney, and tumor biodistribution and kinetics for 111In Pentetreotide and 131I-MIBG in adults and children with neuroendocrine tumors. Then, using the program we have already developed, we will input the individual dosimetry measures for bone marrow, kidney and tumor to determine the optimal amounts of administered radioactivity for the combination of 131I MIBG plus 90Y DOTATOC or 131I MIBG alone.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Other: 131-I MIBG and 111-In pentetreotide
    Subjects will receive 131I MIBG and 111In pentetreotide(surrogate for Y90-DOTATOC)
  • Other: 131-I MIBG and In-111 DOTATATE
    131I MIBG and In-111 DOTATATE (surrogate for 177Lu DOTATATE)
Study Arms  ICMJE
  • Active Comparator: 131-I MIBG and 111I-n pentetreotide
    131-I MIBG and 111I-n pentetreotide
    Intervention: Other: 131-I MIBG and 111-In pentetreotide
  • Active Comparator: 131-I MIBG and In-111 DOTATATE
    131-I MIBG and In-111 DOTATATE
    Intervention: Other: 131-I MIBG and In-111 DOTATATE
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2010)
40
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with biopsy-proven metastatic (soft tissue) neuroendocrine tumors.
  • Subjects with a Southwest Oncology Group (SWOG) performance score of 0-2 and an expected median survival of at least 6 months.
  • The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
  • Subjects must be >18 years of age

Exclusion Criteria:

  • Subjects who use medications that are known to interfere with MIBG uptake and is unable to discontinue for medical reasons.
  • Prior chemotherapy, radiotherapy or any investigational drugs within 60 days prior admission into this study. Patients must have recovered from all therapy-related toxicities
  • Renal insufficiency with a serum creatinine 2 X ULN
  • Subjects unable to lie still for the imaging studies.
  • Subjects who because of their weight and body distribution do not fit into the imaging machine.
  • Subjects receiving Sandostatin LAR < 21 days prior to dosing or Sandostatin Immediate Release (IR) < 24 hours prior to dosing.
  • Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 48 hours prior to administration of study treatment.
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 NCT01099228
Other Study ID Numbers  ICMJE 200602763
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Bushnell, University of Iowa
Study Sponsor  ICMJE David Bushnell
Collaborators  ICMJE VA Office of Research and Development
Investigators  ICMJE
Principal Investigator: David Bushnell, M.D. University of Iowa; Veteran Affairs
PRS Account University of Iowa
Verification Date July 2016

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