Neuroendocrine TumorsNCT01099228
Combination Targeted Radiotherapy in Neuroendocrine Tumors
A study testing 131-I MIBG and 111-In pentetreotide and 131-I MIBG and In-111 DOTATATE in people with Neuroendocrine Tumors, run by David Bushnell at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 131-I MIBG and 111-In pentetreotide and 131-I MIBG and In-111 DOTATATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52242
Department of Veteran Affairs Medical Center
Iowa City, Iowa, 52246
About this study
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.
Read the 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 131-I MIBG and 111-In pentetreotide, 131-I MIBG and In-111 DOTATATE
- Keywords
- Neuroendocrine Tumor, Imaging
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131-I MIBG and 111-In pentetreotideOther
Subjects will receive 131I MIBG and 111In pentetreotide(surrogate for Y90-DOTATOC)
131-I MIBG and In-111 DOTATATEOther
131I MIBG and In-111 DOTATATE (surrogate for 177Lu DOTATATE)
| Study group | Role | What they receive |
|---|---|---|
| 131-I MIBG and 111I-n pentetreotide | Active comparator | 131-I MIBG and 111I-n pentetreotide Receives: Other: 131-I MIBG and 111-In pentetreotide |
| 131-I MIBG and In-111 DOTATATE | Active comparator | 131-I MIBG and In-111 DOTATATE Receives: Other: 131-I MIBG and In-111 DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry Results
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
Measured: 1 week after scan
Secondary outcomes (1)
Maximum Radiation Dose
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..
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2010 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Bushnell
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor-investigator, David Bushnell, University of Iowa
- Investigators
- David Bushnell, M.D., Principal investigator, University of Iowa; Veteran Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099228
- Sponsor's protocol ID
- 200602763
- Status last verified
- Jul 2016
- First submitted
- 26 Mar 2010
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Targeted Radiotherapy in Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT01099228
- Acronym / sponsor ID
- 200602763
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine Tumor, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- David BushnellUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 131-I MIBG and 111I-n pentetreotide | Active comparator | Other: 131-I MIBG and 111-In pentetreotide131-I MIBG and 111I-n pentetreotide |
| 131-I MIBG and In-111 DOTATATE | Active comparator | Other: 131-I MIBG and In-111 DOTATATE131-I MIBG and In-111 DOTATATE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 131-I MIBG and 111-In pentetreotideSubjects will receive 131I MIBG and 111In pentetreotide(surrogate for Y90-DOTATOC) | Other | 131-I MIBG and 111I-n pentetreotide |
| 131-I MIBG and In-111 DOTATATE131I MIBG and In-111 DOTATATE (surrogate for 177Lu DOTATATE) | Other | 131-I MIBG and In-111 DOTATATE |
Primary outcome
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
1 secondary outcome
Maximum Radiation Dose
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bushnell, M.D. principal investigator
University of Iowa; Veteran Affairs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 131-I MIBG and 111-In pentetreotide and 131-I MIBG and In-111 DOTATATE in people with Neuroendocrine Tumors, run by David Bushnell at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry Results (time frame: 1 week after scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.