Gastro-enteropancreatic Neuroendocrine TumorPhase 1/2SPORE-3NCT04614766
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
A Phase 1/2 study testing Lutathera and Azedra in people with Gastro-enteropancreatic Neuroendocrine Tumor and Neuroendocrine Tumors, run by David Bushnell at 1 site in United States.
Trial summary
This study is designed to identify the best tolerated doses of Lutathera® and Azedra® when co-administered to treat midgut neuroendocrine tumors. These drugs are radioactive drugs, known as radionuclide therapy, and are both approved in the treatment of midgut neuroendocrine tumor as single agents (not together). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastro-enteropancreatic Neuroendocrine Tumor, Neuroendocrine Tumors
- What is being tested?
- Lutathera and Azedra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 23 Apr 2024
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to provide informed consent; legally authorized representative will not be utilized compliant with the principles of good clinical practice (i.e., ICH E6(R2)).
- Stated willingness to comply with all study procedures and availability for duration of study
- Aged ≥ 18 years to 80 years at the time of study drug administration
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be:
- a well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2) with a primary tumor location believed to be midgut, or,
- pheochromocytoma, or,
Show all 12Show fewer
- paraganglioma
- Recommended to receive LUTATHERA® or AZEDRA® therapy
- Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST
- Adequate performance status (ECOG of 0 or 1; or KPS of >70).
- Agrees to contraception during therapy.
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient with increased fall risk in the opinion of healthcare professionals
- Women who are pregnant.
- Women who are breast feeding.
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1. (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
- Prior peptide-receptor radiotherapy (PRRT).
Show all 19Show fewer
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).
- A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound/negatively impact study objectives (documentation of the rationale must be provided).
- History of congestive heart failure with a history of cardiac ejection fraction ≤ 35%.
- Patients unable to discontinue medications known to affect MIBG uptake (unless approved by the PI or designee)
- Proteinuria grade 2 (i.e., 2+ proteinuria).
- Prior external beam radiation dose of >16 Gy to the kidneys.
- Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of 5 Gy) as estimated by a radiation oncologist.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.
- Participants meeting the above criteria will receive one cycle of standard Lutathera treatment (200 millicuries) as well as a tracer dose of Azedra for imaging. Participants will then undergo protocol specific imaging to calculate the radiation dose to the kidneys, the bone marrow, and to the tumor lesions.
- To continue on study and receive the combined therapy, a participant's imaging must demonstrate one of the following:
- At least one tumor that is positive for Azedra but negative for Lutathera in addition to Lutathera positive tumors, or,
- At least one tumor site where the calculated safe radiation dose to that tumor site is 25% higher using the combined therapy compared to Lutathera alone
- Participants who do not meet this criteria are invited to participate in the comparator arm to receive standard Lutathera treatment as indicated by their physicians.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
Official title: A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors
This study is designed to identify the best tolerated doses of Lutathera® and Azedra® when co-administered to treat midgut neuroendocrine tumors. These drugs are radioactive drugs, known as radionuclide therapy, and are both approved in the treatment of midgut neuroendocrine tumor as single agents (not together). Currently, the safest and best tolerated doses of these drugs (when combined) is unknown. That is the purpose of this clinical trial.
Read the detailed description
Azedra and Lutatheraare are FDA-approved radioactive drugs designed to treat specific tumor cells. These drugs are a combination of the radiation (131-Iodine, 177-lutetium) and a protein that targets the tumor cell (MIBG or DOTATATE). Because these proteins are attracted to, and stick to, the tumor, the radiation is centered in the tumors. This kills more tumor cells and minimizes radiation-damage to healthy tissues, like the heart and lungs.
Two organs still absorb some of the radiation, though: bone marrow and the kidney. These organs limit how much radiation can be given to tumors, but we don't know how much radiation is too much. Too much radiation to bone marrow can result in anemia. Too much radiation to the kidneys can result in kidney failure. From prior radiation therapies, we have a general idea of how much radiation we can give safely.
Azedra and Lutathera have never been given together. We want to give them together because many times, tumors are actually groups of different types of cells. This means, not all the cells respond to therapy the same way. If some tumor cells survive therapy, the tumor will continue to grow and eventually come back. We know some mid-gut neuroendocrine tumors (NETs) have targets for DOTATATE and some other mid-gut NETs have targets for MIBG. We also have now identified that some people with mid-gut NETs have different tumors: some with targets for MIBG and some with targets for DOTATATE. For these people, this means treating only with Azedra or Lutathera will not be enough to treat their cancer. They need both radioactive drugs.
Because we are combining these radioactive drugs, this study is known as a first-in-man study. We are also using a special imaging to help us estimate the radiation dose to the bone marrow and to the kidneys. This is what decides the final dose of Azedra and Lutathera.
After receiving a standard treatment of Lutathera, participants are asked to undergo imaging to verify they have both MIBG and DOTATATE tumor types:
- participants are given a tracer dose of Azedra
- a special camera (SPECT/CT) collects images (scans)
- imaging (scans) are done over 4 calendar days
- blood samples are taken at that time, too, to measure the circulating amount of tracer doses
If the scans show a participant does not have both MIBG and DOTATATE receptors, they continue with standard therapy (Lutathera only). Participants are asked to still undergo study assessments to provide a comparison group.
If the scans show a participant has both MIBG and DOTATATE receptors, combined therapy is administered:
- a customized dose of Lutathera is given on day 1 of a treatment cycle. This is given outpatient.
- a customized dose of Azedra is given on day 2 of a treatment cycle. This is given inpatient (admitted to the hospital).
- participants are monitored through blood tests to identify the side effects of therapy.
Each participant can have up to 2 cycles of therapy. The cycles are 12 weeks apart.
The doses for Lutathera and Azedra are decided based on radiation to the bone marrow and radiation to the kidney. Doses are decided by how well other participants have done on this study.
Participants have life long follow-up for this study. This is very important, because a study like this has not been done.
- Being tested
- Lutathera, Azedra
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutatheraDrug
Also called lutetium Lu 177 dotatate
intravenous administration
AzedraDrug
Also called iobenguane I-131
intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | Combined treatment with Lutathera® and Azedra® Administered amounts of each drug are based on imaging and radiation dose constraints to the kidneys and the bone marrow. The drug administration is individualized to each participant. Receives: Drug: Lutathera; Drug: Azedra |
| Lutathera® only | Active comparator | Single agent Lutathera® administered per standard of care: 200 millicuries of drug every 8 weeks for a total of 4 doses. Receives: Drug: Lutathera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the kidneys
MTD will be determined by incidence of renal AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Measured: 9 months after initial treatment
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the bone marrow.
MTD will be determined by incidence of hematologic AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Measured: 9 months
Phase 2: Objective Response Rate (ORR)
Objective response rate, measured using standardized RECIST criteria, is a reflection of complete tumor response and partial tumor response when obtained at 6 months and 12 months post-treatment.
Measured: 6 months post-treatment
Phase 2: Objective Response Rate (ORR)
Objective response rate, measured using standardized RECIST criteria, is a reflection of complete tumor response and partial tumor response when obtained at 6 months and 12 months post-treatment.
Measured: 12 months post-treatment
Secondary outcomes (3)
Tumor size
Determine tumor size and response using RECIST 1.1 criteria in patients treated with the combined regimen
Measured: 6 months post-treatment
Tumor size
Determine tumor size and response using RECIST 1.1 criteria in patients treated with the combined regimen
Measured: 12 months post-treatment
Number of Treatment-Related Adverse Events
Categorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (v5)
Measured: Up to 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start30 Sep 2022
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Why it stopped: Azedra withdrawn from US market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastro-enteropancreatic Neuroendocrine TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants who do not meet eligibility criteria for the combined therapy will be asked to participate in the active comparator, which is single agent Lutathera administered as per FDA guidelines.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Bushnell
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Progenics Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, David Bushnell, University of Iowa
- Investigators
- David Bushnell, M.D., Principal investigator, The University of Iowa and the Iowa City VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614766
- Sponsor's protocol ID
- 202005556
- Other IDs
- P50CA174521
- Acronym
- SPORE-3
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2020
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants must opt in to data sharing. For those that do, imaging, adverse event, and treatment data will be provided.
Publications
Madsen MT, Bushnell DL, Juweid ME, Menda Y, O'Dorisio MS, O'Dorisio T, Besse IM. Potential increased tumor-dose delivery with combined 131I-MIBG and 90Y-DOTATOC treatment in neuroendocrine tumors: a theoretic model. J Nucl Med. 2006 Apr;47(4):660-7.
PubMed 16595501Bushnell DL, Madsen MT, O'cdorisio T, Menda Y, Muzahir S, Ryan R, O'dorisio MS. Feasibility and advantage of adding (131)I-MIBG to (90)Y-DOTATOC for treatment of patients with advanced stage neuroendocrine tumors. EJNMMI Res. 2014 Dec;4(1):38. doi: 10.1186/s13550-014-0038-2. Epub 2014 Sep 10.
PubMed 26116109
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT04614766
- Acronym / sponsor ID
- SPORE-3 / 202005556
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Azedra withdrawn from US market
- Enrolment
- 0 participants (actual)
- Lead sponsor
- David BushnellUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Progenics Pharmaceuticals, Inc.
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 4 Nov 2020 (actual)
- 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.
This study is designed to identify the best tolerated doses of Lutathera® and Azedra® when co-administered to treat midgut neuroendocrine tumors. These drugs are radioactive drugs, known as radionuclide therapy, and are both approved in the treatment of midgut neuroendocrine tumor as single agents (not together). Currently, the safest and best tolerated doses of these drugs (when combined) is unknown. That is the purpose of this clinical trial.
Detailed description
Azedra and Lutatheraare are FDA-approved radioactive drugs designed to treat specific tumor cells. These drugs are a combination of the radiation (131-Iodine, 177-lutetium) and a protein that targets the tumor cell (MIBG or DOTATATE). Because these proteins are attracted to, and stick to, the tumor, the radiation is centered in the tumors. This kills more tumor cells and minimizes radiation-damage to healthy tissues, like the heart and lungs.
Two organs still absorb some of the radiation, though: bone marrow and the kidney. These organs limit how much radiation can be given to tumors, but we don't know how much radiation is too much. Too much radiation to bone marrow can result in anemia. Too much radiation to the kidneys can result in kidney failure. From prior radiation therapies, we have a general idea of how much radiation we can give safely.
Azedra and Lutathera have never been given together. We want to give them together because many times, tumors are actually groups of different types of cells. This means, not all the cells respond to therapy the same way. If some tumor cells survive therapy, the tumor will continue to grow and eventually come back. We know some mid-gut neuroendocrine tumors (NETs) have targets for DOTATATE and some other mid-gut NETs have targets for MIBG. We also have now identified that some people with mid-gut NETs have different tumors: some with targets for MIBG and some with targets for DOTATATE. For these people, this means treating only with Azedra or Lutathera will not be enough to treat their cancer. They need both radioactive drugs.
Because we are combining these radioactive drugs, this study is known as a first-in-man study. We are also using a special imaging to help us estimate the radiation dose to the bone marrow and to the kidneys. This is what decides the final dose of Azedra and Lutathera.
After receiving a standard treatment of Lutathera, participants are asked to undergo imaging to verify they have both MIBG and DOTATATE tumor types:
- participants are given a tracer dose of Azedra
- a special camera (SPECT/CT) collects images (scans)
- imaging (scans) are done over 4 calendar days
- blood samples are taken at that time, too, to measure the circulating amount of tracer doses
If the scans show a participant does not have both MIBG and DOTATATE receptors, they continue with standard therapy (Lutathera only). Participants are asked to still undergo study assessments to provide a comparison group.
If the scans show a participant has both MIBG and DOTATATE receptors, combined therapy is administered:
- a customized dose of Lutathera is given on day 1 of a treatment cycle. This is given outpatient.
- a customized dose of Azedra is given on day 2 of a treatment cycle. This is given inpatient (admitted to the hospital).
- participants are monitored through blood tests to identify the side effects of therapy.
Each participant can have up to 2 cycles of therapy. The cycles are 12 weeks apart.
The doses for Lutathera and Azedra are decided based on radiation to the bone marrow and radiation to the kidney. Doses are decided by how well other participants have done on this study.
Participants have life long follow-up for this study. This is very important, because a study like this has not been done.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who do not meet eligibility criteria for the combined therapy will be asked to participate in the active comparator, which is single agent Lutathera administered as per FDA guidelines.
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: Lutathera, Drug: AzedraCombined treatment with Lutathera® and Azedra® Administered amounts of each drug are based on imaging and radiation dose constraints to the kidneys and the bone marrow. The drug administration is individualized to each participant. |
| Lutathera® only | Active comparator | Drug: LutatheraSingle agent Lutathera® administered per standard of care: 200 millicuries of drug every 8 weeks for a total of 4 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand and willingness to provide informed consent; legally authorized representative will not be utilized compliant with the principles of good clinical practice (i.e., ICH E6(R2)).
- Stated willingness to comply with all study procedures and availability for duration of study
- Aged ≥ 18 years to 80 years at the time of study drug administration
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be:
- Recommended to receive LUTATHERA® or AZEDRA® therapy
Key exclusion criteria (19 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patient with increased fall risk in the opinion of healthcare professionals
- Women who are pregnant.
- Women who are breast feeding.
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1. (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
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 |
|---|---|---|
| LutatheraAlso: lutetium Lu 177 dotatateintravenous administration | Drug | Combination Therapy, Lutathera® only |
| AzedraAlso: iobenguane I-131intravenous administration | Drug | Combination Therapy |
Primary outcome
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the kidneys
Time frame: 9 months after initial treatment
MTD will be determined by incidence of renal AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the bone marrow.
Time frame: 9 months
MTD will be determined by incidence of hematologic AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Phase 2: Objective Response Rate (ORR)
Time frame: 6 months post-treatment
Objective response rate, measured using standardized RECIST criteria, is a reflection of complete tumor response and partial tumor response when obtained at 6 months and 12 months post-treatment.
Phase 2: Objective Response Rate (ORR)
Time frame: 12 months post-treatment
Objective response rate, measured using standardized RECIST criteria, is a reflection of complete tumor response and partial tumor response when obtained at 6 months and 12 months post-treatment.
3 secondary outcomes
Tumor size
Time frame: 6 months post-treatment
Tumor size
Time frame: 12 months post-treatment
Number of Treatment-Related Adverse Events
Time frame: Up to 24 months post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Background: PubMed 16595501Madsen MT, Bushnell DL, Juweid ME, Menda Y, O'Dorisio MS, O'Dorisio T, Besse IM. Potential increased tumor-dose delivery with combined 131I-MIBG and 90Y-DOTATOC treatment in neuroendocrine tumors: a theoretic model. J Nucl Med. 2006 Apr;47(4):660-7.
- Background: PubMed 26116109Bushnell DL, Madsen MT, O'cdorisio T, Menda Y, Muzahir S, Ryan R, O'dorisio MS. Feasibility and advantage of adding (131)I-MIBG to (90)Y-DOTATOC for treatment of patients with advanced stage neuroendocrine tumors. EJNMMI Res. 2014 Dec;4(1):38. doi: 10.1186/s13550-014-0038-2. Epub 2014 Sep 10.
- Individual participant dataSharing planned: Yes. Participants must opt in to data sharing. For those that do, imaging, adverse event, and treatment data will be provided.
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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
The University of Iowa and the Iowa City VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lutathera and Azedra in people with Gastro-enteropancreatic Neuroendocrine Tumor and Neuroendocrine Tumors, run by David Bushnell at 1 site 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 12 inclusion and 19 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: withdrawn, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase 1: Determination of maximum tolerated radiation dose (MTD) to the kidneys (time frame: 9 months after initial treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614766, which also lists 2 linked publications.
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 29 Apr 2024.