NeuroblastomaPhase 1/2NCT00798148
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
A Phase 1/2 study testing 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation in people with Neuroblastoma, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial summary
This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIran
- Study dates
- Sep 2008to Jul 2012
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
- High risk according COG (Children Oncology Group)OR Relapse OR Refractory
- As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan
- Glomerular filtration rate or creatinine clearance > 60 ml/min
- No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection
- No active infection
Who cannot join
- Impaired renal function
- No avid I131-MIBG lesion
- Active infection
Trial locations and contacts
2 sites in 1 country.
Amir Ali Hamidieh, M.D. contact
Iran2 sites, 2 recruiting
- Recruiting
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, 14114
Amir Ali Hamidieh, M.D., aahamidieh@sina.tums.ac.ir
Amir Ali Hamidieh, M.D.
- Recruiting
Research Institute for Nuclear Medicine
Tehran, Tehran Province, 14114
Babak Fallahi, M.D., bfallahi@sina.tums.ac.ir
Babak Fallahi, M.D.
About this study
Official title: Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.
- Conditions
- Neuroblastoma
- Being tested
- 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation
- Keywords
- Neuroblastoma, MIBG, Autologous Peripheral Stem Cell Transplantation
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell TransplantationDrug
131I-MIBG 12mci/kg CEM(Etoposide)=1200mg/m2 Melphalan=210mg/m2 Carboplatin=1500mg/m2 Autologous Peripheral Stem Cell Transplantation
| Study group | Role | What they receive |
|---|---|---|
| MIBG | Experimental | Not described Receives: Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
Measured: one-years post stem cell transplantation
Secondary outcomes (1)
Overall survival
Measured: one-year after stem cell tranplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2012 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798148
- Sponsor's protocol ID
- 87-01-36-6853
- Status last verified
- May 2012
- First submitted
- 23 Nov 2008
- Last updated
- 4 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT00798148
- Acronym / sponsor ID
- 87-01-36-6853
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, MIBG, Autologous Peripheral Stem Cell Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2012 (estimated)
- First posted
- 25 Nov 2008 (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 trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIBG | Experimental | Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
- High risk according COG (Children Oncology Group)OR Relapse OR Refractory
- As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan
- Glomerular filtration rate or creatinine clearance > 60 ml/min
- No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection
Key exclusion criteria (3 listed)
- Impaired renal function
- No avid I131-MIBG lesion
- Active infection
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 |
|---|---|---|
| 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation131I-MIBG 12mci/kg CEM(Etoposide)=1200mg/m2 Melphalan=210mg/m2 Carboplatin=1500mg/m2 Autologous Peripheral Stem Cell Transplantation | Drug | MIBG |
Primary outcome
Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
Time frame: one-years post stem cell transplantation
1 secondary outcome
Overall survival
Time frame: one-year after stem cell tranplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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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.
Amir Ali Hamidieh, M.D. contact
2 sites 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 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation in people with Neuroblastoma, run by Tehran University of Medical Sciences at 2 sites in Iran.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jun 2012. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Ali Hamidieh, M.D. (aahamidieh@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation (time frame: one-years post stem cell transplantation). 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 4 Jun 2012.