NeuroblastomaPhase 2NCT00992173
Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
A Phase 2 study testing Ultratrace Iobenguane I 131 in people with Neuroblastoma, run by Molecular Insight Pharmaceuticals, Inc. at 21 sites in 2 countries.
Trial summary
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side… Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Ultratrace Iobenguane I 131
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jan 2010to Oct 2011
- Phase
- Phase 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients will be excluded if any of the following conditions are observed:
- Pregnant, or lactating females with the intent to breast feed. Females of child-bearing potential must have a negative serum pregnancy test prior to therapy. Males and females of reproductive age and childbearing potential must use effective contraception defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant for the duration of their participation. Sexually active female patients using oral contraception will be required to use a second form of barrier birth control. All patients will be required to use effective contraception for 60 days following the last therapeutic dose of Ultratrace iobenguane I 131.
- Have disease of any major organ system that would compromise their ability to withstand therapy.
- Receiving hemodialysis or have a renal obstruction, which would effect the urinary excretion of MIBG.
- Is platelet transfusion dependent
- Status post-allogeneic hematopoietic stem cell transplant.
Show all 12Show fewer
- Concomitant use of medications that inhibit uptake of Ultratrace iobenguane I 131.
- Have a known allergy to iobenguane, iodine or SSKI.
- If patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation or imaging requirements (sedation or general anesthesia permitted).
- Administered prior chemotherapy within 30 days of study entry or have active malignancy (other than neuroblastoma) requiring additional treatment.
- Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
- Patient unable to receive at least one 15 mCi/kg dose per dosimetry findings.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
CS Motts Children's Hospital
Ann Arbor, Michigan, 48105
Johns Hopkins University
Baltimore, Maryland, 21287
Children's Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Childrens Memorial/Northwestern University
Chicago, Illinois, 60614
Comer's Childrens Hospital/University of Chicago
Chicago, Illinois, 60637
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
Cook Children's Healthcare System
Fort Worth, Texas, 76104
MD Anderson Cancer Center
Houston, Texas, 77030
Texas Childrens Hospital Cancer Center
Houston, Texas, 77030
University of iowa
Iowa City, Iowa, 52242
Children's Hospital of LA
Los Angeles, California, 90027
University of Wisconsin Medical Center
Madison, Wisconsin, 53792
University of Miami Miller School of Medicine
Miami, Florida, 33136
Mount Sinai School of Medicine
New York, New York, 10029
Hospital - Weill Cornell Medical Center
New York, New York, 10032
Memorial Sloan Kettering
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UCSF Pediatric Hematology/Oncology
San Francisco, California, 94143
About this study
Official title: A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die.
In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.
- Conditions
- Neuroblastoma
- Being tested
- Ultratrace Iobenguane I 131
- Keywords
- Neuroblastoma, MIBG, Iobenguane
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultratrace Iobenguane I 131Drug
Subjects will receive an Imaging Dose of 0.1 mCi/kg [3.7 MBq/kg] (a minimum dose of 1.0 mCi [37 MBq] but not to exceed 5.0 mCi [185 MBq]) of Ultratrace iobenguane I 131 to have dosimetry performed and to confirm tumor uptake of the test article prior to receiving each of 2 planned Therapeutic Doses of Ultratrace iobeneguane I 131 . Within 28 days of screening, eligible subjects (as confirmed by the first Imaging dose study)will receive an Ultratrace iobenguane I 131 Therapeutic dose of of 15.0 - 18.0 mCi/kg (max. 666 MBq/kg) followed by imaging 7 days later or upon discharge from radiation isolation. A second Therapeutic Dose (preceded by a repeat Image Dose and dosimetry study)and imaging upon discharge from radiation isolation will be repeated approximately 8 weeks after the first dose.
| Study group | Role | What they receive |
|---|---|---|
| Ultratrace Iobenguane I 131 | Experimental | Not described Receives: Drug: Ultratrace Iobenguane I 131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete or partial response, sustained over two assessments, following treatment. Response criteria for the primary endpoint are based on the International Neuroblastoma Response Criteria (INRC).
Measured: Weeks 8, 16, 26, 39 and 52 after treatment
Secondary outcomes (4)
Change in use of narcotics for pain management
Measured: Weeks 8, 16, 26, 39 and 52 after treatment
Change in patient quality of life
Measured: Weeks 8, 16, 26, 39 and 52 after treatment
Change in key tumor markers (HVA and VMA)
Measured: Weeks 8, 16, 26, 39 and 52 after treatment
Overall survival
Measured: Weeks 8, 16, 26, 39 and 52 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norman LaFrance, MD, Study director, Molecular Insight Pharmaceutical Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992173
- Sponsor's protocol ID
- MIP-IB-N201
- Status last verified
- Nov 2015
- First submitted
- 7 Oct 2009
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT00992173
- Acronym / sponsor ID
- MIP-IB-N201
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, MIBG, Iobenguane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- First posted
- 9 Oct 2009 (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.
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die.
In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultratrace Iobenguane I 131 | Experimental | Drug: Ultratrace Iobenguane I 131 |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Pregnant, or lactating females with the intent to breast feed. Females of child-bearing potential must have a negative serum pregnancy test prior to therapy. Males and females of reproductive age and childbearing potential must use effective contraception defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant for the duration of their participation. Sexually active female patients using oral contraception will be required to use a second form of barrier birth control. All patients will be required to use effective contraception for 60 days following the last therapeutic dose of Ultratrace iobenguane I 131.
- Have disease of any major organ system that would compromise their ability to withstand therapy.
- Receiving hemodialysis or have a renal obstruction, which would effect the urinary excretion of MIBG.
- Is platelet transfusion dependent
- Status post-allogeneic hematopoietic stem cell transplant.
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 |
|---|---|---|
| Ultratrace Iobenguane I 131Subjects will receive an Imaging Dose of 0.1 mCi/kg [3.7 MBq/kg] (a minimum dose of 1.0 mCi [37 MBq] but not to exceed 5.0 mCi [185 MBq]) of Ultratrace iobenguane I 131 to have dosimetry performed and to confirm tumor uptake of the test article prior to receiving each of 2 planned Therapeutic Doses of Ultratrace iobeneguane I 131 . Within 28 days of screening, eligible subjects (as confirmed by the first Imaging dose study)will receive an Ultratrace iobenguane I 131 Therapeutic dose of of 15.0 - 18.0 mCi/kg (max. 666 MBq/kg) followed by imaging 7 days later or upon discharge from radiation isolation. A second Therapeutic Dose (preceded by a repeat Image Dose and dosimetry study)and imaging upon discharge from radiation isolation will be repeated approximately 8 weeks after the first dose. | Drug | Ultratrace Iobenguane I 131 |
Primary outcome
Proportion of patients with complete or partial response, sustained over two assessments, following treatment. Response criteria for the primary endpoint are based on the International Neuroblastoma Response Criteria (INRC).
Time frame: Weeks 8, 16, 26, 39 and 52 after treatment
4 secondary outcomes
Change in use of narcotics for pain management
Time frame: Weeks 8, 16, 26, 39 and 52 after treatment
Change in patient quality of life
Time frame: Weeks 8, 16, 26, 39 and 52 after treatment
Change in key tumor markers (HVA and VMA)
Time frame: Weeks 8, 16, 26, 39 and 52 after treatment
Overall survival
Time frame: Weeks 8, 16, 26, 39 and 52 after 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 26 Nov 2015.
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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.
Norman LaFrance, MD study director
Molecular Insight Pharmaceutical Employee
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultratrace Iobenguane I 131 in people with Neuroblastoma, run by Molecular Insight Pharmaceuticals, Inc. at 21 sites in 2 countries.
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 0 inclusion and 12 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 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. 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 phase mean?
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?
Proportion of patients with complete or partial response, sustained over two assessments, following treatment. Response criteria for the primary endpoint are based on the International Neuroblastoma Response Criteria (INRC). (time frame: Weeks 8, 16, 26, 39 and 52 after treatment). 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 26 Nov 2015.