Brain CancerPhase 1NCT01502917
Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
A Phase 1 study testing Radioactive iodine-labeled monoclonal antibody omburtamab and External Beam Radiotherapy in people with Brain Cancer and Brain Stem Glioma, run by Y-mAbs Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to deliver an agent called 124I-omburtamab. CED is performed during surgery. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Brain Cancer, Brain Stem Glioma
- What is being tested?
- Radioactive iodine-labeled monoclonal antibody omburtamab and External Beam Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Jan 2022
- Phase
- Phase 1
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Consensus of diagnosis must be reached by a multidisciplinary pediatric neuro-oncology team by considering both clinical evidence and MRI presentation. Tissue diagnosis is not required.
- The patient must have undergone prior external beam radiotherapy to a dose of 54-60 Gy to the brain stem. At least 4 weeks but no more than 14 weeks must have elapsed from the completion of radiotherapy.
- The patient must be in adequate general condition for study, with Lansky or Karnofsky Performance Score of ≥ 50 at study entry .
- Lansky Performance scale will be used for patients ≤16 years of age.
- The patient must be ≥ 2 and ≤ 21 years old.
- Patient must weigh a minimum of 8 kg.
Who cannot join
- Clinical and/or radiographic (MRI) progression of tumor following external beam radiation therapy.
- Metastatic disease.
- Untreated symptomatic hydrocephalus determined by treating physician.
- AST or ALT > 2x the upper limit of normal.
- Platelets < 100,000/mcL.
- ANC < 1000/mcL.
Show all 9Show fewer
- Abnormal PT (Inr) >1.5 INR or PTT > 42 sec (may be corrected with FFP, cryoprecipitate, vitamin K, etc).
- Total bilirubin > 2.0 mg/dl.
- Serum creatinine > 1.5x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR < 70 ml/min/1.73 m2.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Weill Medical College of Cornell University
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I Study of Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to deliver an agent called 124I-omburtamab. CED is performed during surgery. The study agent is infused through a small tube placed into the tumor in the brain. Many studies have shown this can safely be done in animals but this study is the first time 124I-omburtamab will be given by CED in humans. This will be one of the first times that CED has been performed in the brain stem.
Omburtamab is something called an antibody. Antibodies are made by the body to fight infections and sometimes cancer. The antibody omburtamab is produced by mice and can attack many kinds of tumors. A radioactive substance, 124I-omburtamab, is attached to omburtamab. 124I-omburtamab sticks to parts of tumor cells and can cause the tumor cells to die from radiation. Studies have also been done on humans using 124I-omburtamab to treat other kinds of cancer. Our studies of some DPG and related tumors suggest that omburtamab will bind to the tumor, but the investigators don't know that for sure.
In this study, the researchers want to find out how safe 124I-omburtamab given by CED is at different dose levels. They will look to see what effects (both good and bad) it has on the patient. The dose of 124I-omburtamab will increase for each new group of patients. The procedure has already been safely performed with lower doses and infusion volumes in a number of patients here at MSKCC. The amount they get will depend on when they enter the study. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some more patients may be treated with a lower dose to make sure that dose is safe.
- Conditions
- Brain Cancer, Brain Stem Glioma
- Being tested
- Radioactive iodine-labeled monoclonal antibody omburtamab, External Beam Radiotherapy
- Keywords
- Brain stem glioma, CNS, MAB 124I-omburtamab, infusion cannula, DIPG, Diffuse Intrinsic Pontine Glioma, 11-011
- Medical subject headings
- Brain Neoplasms, Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive iodine-labeled monoclonal antibody omburtamabDrug
Prior to treatment children will be pre-medicated with super-saturated potassium iodide \& liothyronine to prevent thyroid uptake of the therapeutic radioisotopes. The proposed intervention is a surgical procedure using interstitial infusion of the radiolabeled monoclonal antibody 124I-omburtamab into the brain stem tumor. This will be performed by stereotactic placement of a small caliber infusion cannula into the tumor followed by a slow infusion (CED) of 124I-omburtamab. Following treatment, these children will be monitored during inpatient hospitalization with clinical evaluations \& PET/CT or PET/MRI scans of the brain \& other organs. Clinical observations, intensive care unit monitoring, routine blood \& interval imaging studies (MRI \& PET/CT or PET/MRI scans) will be performed at predetermined time points. If the PET/CT scan happens to fall on a weekend or holiday, the scan may be done before or after at the discretion of the Study PI. This will not affect dosimetry interpretation.
External Beam RadiotherapyRadiation
Standard radiation therapy is given 4-6 weeks prior to study entry.
| Study group | Role | What they receive |
|---|---|---|
| Radioactive iodine-labeled monoclonal antibody omburtamab | Experimental | This is a therapeutic Phase I study intended to assess the safety of convection-enhanced delivery (CED) of radioimmunotherapy in the treatment of children with diffuse pontine glioma. Receives: Drug: Radioactive iodine-labeled monoclonal antibody omburtamab; Radiation: External Beam Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
Determination that a dose is safe will be made following the treatment of at least 3 but no more than 6 patients at a particular dose level. The dose levels are DL1 (0.25 mCi), DL2 (0.5 mCi), DL3 (0.75 mCi), DL4 (1.0 mCi) DL5 (2.5mCi), DL6 (3.25mCi), DL7 (4.0mCi), DL 7.1(4.0mCi), DL 7.2 (4.0mCi), DL 8 (6.0mCi), DL 9 (8.0mCi), DL 10 (10.0mCi), DL 11 (12.0mCi) ,fallback DL0 (0.125 mCi) FB1 (1.50mCi) and FB2 (2.0mCi). An incidence of dose-limiting toxicity (DLT) in the range of 25% is considered acceptable in this population. A maximum tolerated dose (MTD) will be defined as the dose level below that at which 2 DLTs have occurred.
Measured: 2 years
assess the toxicity profile
Adverse events (toxicity) will be assessed and classified according to the Clinical Terminology Criteria for Adverse Events version 4.0 (CTCAE). Generally, grade 3 toxicities interfere with activities of daily living (ADLs) and grade 4 toxicities are life-threatening. Grade 5 toxicities cause death.
Measured: 2 years
Secondary outcomes (1)
overall survival
Overall survival from the time of diagnosis will be recorded for every patient in this study. Overall survival will be estimated by Kaplan-Meier methodology.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Y-mAbs Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Mark Souweidane, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502917
- Sponsor's protocol ID
- 11-011
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2011
- Last updated
- 19 Dec 2023
- Results posted
- No
Publications
Franca Velo A, Giantini Larsen A, Humm JL, Zanzonico P, Haque S, Souweidane M, Pandit-Taskar N. Determination of the Intralesional Distribution of Theranostic 124I-Omburtamab Convection-Enhanced Delivery in Treatment of Diffuse Intrinsic Pontine Glioma. J Nucl Med. 2025 Jun 2;66(6):886-891. doi: 10.2967/jnumed.124.267995.
PubMed 40306974Souweidane MM, Bander ED, Zanzonico P, Reiner AS, Manino N, Haque S, Carrasquillo JA, Lyashchenko SK, Thakur SB, Lewis JS, Donzelli M, Cheung NV, Larson SM, Kramer K, Pandit-Taskar N, Dunkel IJ. Phase 1 dose-escalation trial using convection-enhanced delivery of radio-immunotheranostic 124I-Omburtamab for diffuse intrinsic pontine glioma. Neuro Oncol. 2025 Sep 17;27(8):2117-2126. doi: 10.1093/neuonc/noaf039.
PubMed 39969230Pandit-Taskar N, Zanzonico PB, Grkovski M, Donzelli M, Vietri SM, Horan C, Serencsits B, Prasad K, Lyashchenko S, Kramer K, Dunkel IJ, Souweidane MM. Theranostic Intratumoral Convection-Enhanced Delivery of 124I-Omburtamab in Patients with Diffuse Intrinsic Pontine Glioma: Pharmacokinetics and Lesion Dosimetry. J Nucl Med. 2024 Sep 3;65(9):1364-1370. doi: 10.2967/jnumed.123.266365.
PubMed 39142829Bander ED, Ramos AD, Wembacher-Schroeder E, Ivasyk I, Thomson R, Morgenstern PF, Souweidane MM. Repeat convection-enhanced delivery for diffuse intrinsic pontine glioma. J Neurosurg Pediatr. 2020 Sep 25;26(6):661-666. doi: 10.3171/2020.6.PEDS20280. Print 2020 Dec 1.
PubMed 32977309Morgenstern PF, Zhou Z, Wembacher-Schroder E, Cina V, Tsiouris AJ, Souweidane MM. Clinical tolerance of corticospinal tracts in convection-enhanced delivery to the brainstem. J Neurosurg. 2018 Dec 21;131(6):1812-1818. doi: 10.3171/2018.6.JNS18854. Print 2019 Dec 1.
PubMed 30579270Souweidane MM, Kramer K, Pandit-Taskar N, Zhou Z, Haque S, Zanzonico P, Carrasquillo JA, Lyashchenko SK, Thakur SB, Donzelli M, Turner RS, Lewis JS, Cheung NV, Larson SM, Dunkel IJ. Convection-enhanced delivery for diffuse intrinsic pontine glioma: a single-centre, dose-escalation, phase 1 trial. Lancet Oncol. 2018 Aug;19(8):1040-1050. doi: 10.1016/S1470-2045(18)30322-X. Epub 2018 Jun 18.
PubMed 29914796Ivasyk I, Morgenstern PF, Wembacher-Schroeder E, Souweidane MM. Influence of an intratumoral cyst on drug distribution by convection-enhanced delivery: case report. J Neurosurg Pediatr. 2017 Sep;20(3):256-260. doi: 10.3171/2017.5.PEDS1774. Epub 2017 Jul 7.
PubMed 28686124Guisado DI, Singh R, Minkowitz S, Zhou Z, Haque S, Peck KK, Young RJ, Tsiouris AJ, Souweidane MM, Thakur SB. A Novel Methodology for Applying Multivoxel MR Spectroscopy to Evaluate Convection-Enhanced Drug Delivery in Diffuse Intrinsic Pontine Gliomas. AJNR Am J Neuroradiol. 2016 Jul;37(7):1367-73. doi: 10.3174/ajnr.A4713. Epub 2016 Mar 3.
PubMed 26939629
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
- ClinicalTrials.gov ID
- NCT01502917
- Acronym / sponsor ID
- 11-011
- Conditions
- Brain Cancer, Brain Stem Glioma
- Keywords
- Brain stem glioma, CNS, MAB 124I-omburtamab, infusion cannula, DIPG, Diffuse Intrinsic Pontine Glioma, 11-011
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Y-mAbs TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- Dec 2011 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 2 Jan 2012 (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 purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to deliver an agent called 124I-omburtamab. CED is performed during surgery. The study agent is infused through a small tube placed into the tumor in the brain. Many studies have shown this can safely be done in animals but this study is the first time 124I-omburtamab will be given by CED in humans. This will be one of the first times that CED has been performed in the brain stem.
Omburtamab is something called an antibody. Antibodies are made by the body to fight infections and sometimes cancer. The antibody omburtamab is produced by mice and can attack many kinds of tumors. A radioactive substance, 124I-omburtamab, is attached to omburtamab. 124I-omburtamab sticks to parts of tumor cells and can cause the tumor cells to die from radiation. Studies have also been done on humans using 124I-omburtamab to treat other kinds of cancer. Our studies of some DPG and related tumors suggest that omburtamab will bind to the tumor, but the investigators don't know that for sure.
In this study, the researchers want to find out how safe 124I-omburtamab given by CED is at different dose levels. They will look to see what effects (both good and bad) it has on the patient. The dose of 124I-omburtamab will increase for each new group of patients. The procedure has already been safely performed with lower doses and infusion volumes in a number of patients here at MSKCC. The amount they get will depend on when they enter the study. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some more patients may be treated with a lower dose to make sure that dose is safe.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioactive iodine-labeled monoclonal antibody omburtamab | Experimental | Drug: Radioactive iodine-labeled monoclonal antibody omburtamab, Radiation: External Beam RadiotherapyThis is a therapeutic Phase I study intended to assess the safety of convection-enhanced delivery (CED) of radioimmunotherapy in the treatment of children with diffuse pontine glioma. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Consensus of diagnosis must be reached by a multidisciplinary pediatric neuro-oncology team by considering both clinical evidence and MRI presentation. Tissue diagnosis is not required.
- The patient must have undergone prior external beam radiotherapy to a dose of 54-60 Gy to the brain stem. At least 4 weeks but no more than 14 weeks must have elapsed from the completion of radiotherapy.
- The patient must be in adequate general condition for study, with Lansky or Karnofsky Performance Score of ≥ 50 at study entry .
- Lansky Performance scale will be used for patients ≤16 years of age.
- The patient must be ≥ 2 and ≤ 21 years old.
Key exclusion criteria (9 listed)
- Clinical and/or radiographic (MRI) progression of tumor following external beam radiation therapy.
- Metastatic disease.
- Untreated symptomatic hydrocephalus determined by treating physician.
- AST or ALT > 2x the upper limit of normal.
- Platelets < 100,000/mcL.
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 |
|---|---|---|
| Radioactive iodine-labeled monoclonal antibody omburtamabPrior to treatment children will be pre-medicated with super-saturated potassium iodide \& liothyronine to prevent thyroid uptake of the therapeutic radioisotopes. The proposed intervention is a surgical procedure using interstitial infusion of the radiolabeled monoclonal antibody 124I-omburtamab into the brain stem tumor. This will be performed by stereotactic placement of a small caliber infusion cannula into the tumor followed by a slow infusion (CED) of 124I-omburtamab. Following treatment, these children will be monitored during inpatient hospitalization with clinical evaluations \& PET/CT or PET/MRI scans of the brain \& other organs. Clinical observations, intensive care unit monitoring, routine blood \& interval imaging studies (MRI \& PET/CT or PET/MRI scans) will be performed at predetermined time points. If the PET/CT scan happens to fall on a weekend or holiday, the scan may be done before or after at the discretion of the Study PI. This will not affect dosimetry interpretation. | Drug | Radioactive iodine-labeled monoclonal antibody omburtamab |
| External Beam RadiotherapyStandard radiation therapy is given 4-6 weeks prior to study entry. | Radiation | Radioactive iodine-labeled monoclonal antibody omburtamab |
Primary outcome
maximum tolerated dose
Time frame: 2 years
Determination that a dose is safe will be made following the treatment of at least 3 but no more than 6 patients at a particular dose level. The dose levels are DL1 (0.25 mCi), DL2 (0.5 mCi), DL3 (0.75 mCi), DL4 (1.0 mCi) DL5 (2.5mCi), DL6 (3.25mCi), DL7 (4.0mCi), DL 7.1(4.0mCi), DL 7.2 (4.0mCi), DL 8 (6.0mCi), DL 9 (8.0mCi), DL 10 (10.0mCi), DL 11 (12.0mCi) ,fallback DL0 (0.125 mCi) FB1 (1.50mCi) and FB2 (2.0mCi). An incidence of dose-limiting toxicity (DLT) in the range of 25% is considered acceptable in this population. A maximum tolerated dose (MTD) will be defined as the dose level below that at which 2 DLTs have occurred.
assess the toxicity profile
Time frame: 2 years
Adverse events (toxicity) will be assessed and classified according to the Clinical Terminology Criteria for Adverse Events version 4.0 (CTCAE). Generally, grade 3 toxicities interfere with activities of daily living (ADLs) and grade 4 toxicities are life-threatening. Grade 5 toxicities cause death.
1 secondary outcome
overall survival
Time frame: 2 years
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 19 Dec 2023.
- Derived from this study: PubMed 40306974Franca Velo A, Giantini Larsen A, Humm JL, Zanzonico P, Haque S, Souweidane M, Pandit-Taskar N. Determination of the Intralesional Distribution of Theranostic 124I-Omburtamab Convection-Enhanced Delivery in Treatment of Diffuse Intrinsic Pontine Glioma. J Nucl Med. 2025 Jun 2;66(6):886-891. doi: 10.2967/jnumed.124.267995.
- Derived from this study: PubMed 39969230Souweidane MM, Bander ED, Zanzonico P, Reiner AS, Manino N, Haque S, Carrasquillo JA, Lyashchenko SK, Thakur SB, Lewis JS, Donzelli M, Cheung NV, Larson SM, Kramer K, Pandit-Taskar N, Dunkel IJ. Phase 1 dose-escalation trial using convection-enhanced delivery of radio-immunotheranostic 124I-Omburtamab for diffuse intrinsic pontine glioma. Neuro Oncol. 2025 Sep 17;27(8):2117-2126. doi: 10.1093/neuonc/noaf039.
- Derived from this study: PubMed 39142829Pandit-Taskar N, Zanzonico PB, Grkovski M, Donzelli M, Vietri SM, Horan C, Serencsits B, Prasad K, Lyashchenko S, Kramer K, Dunkel IJ, Souweidane MM. Theranostic Intratumoral Convection-Enhanced Delivery of 124I-Omburtamab in Patients with Diffuse Intrinsic Pontine Glioma: Pharmacokinetics and Lesion Dosimetry. J Nucl Med. 2024 Sep 3;65(9):1364-1370. doi: 10.2967/jnumed.123.266365.
- Derived from this study: PubMed 32977309Bander ED, Ramos AD, Wembacher-Schroeder E, Ivasyk I, Thomson R, Morgenstern PF, Souweidane MM. Repeat convection-enhanced delivery for diffuse intrinsic pontine glioma. J Neurosurg Pediatr. 2020 Sep 25;26(6):661-666. doi: 10.3171/2020.6.PEDS20280. Print 2020 Dec 1.
- Derived from this study: PubMed 30579270Morgenstern PF, Zhou Z, Wembacher-Schroder E, Cina V, Tsiouris AJ, Souweidane MM. Clinical tolerance of corticospinal tracts in convection-enhanced delivery to the brainstem. J Neurosurg. 2018 Dec 21;131(6):1812-1818. doi: 10.3171/2018.6.JNS18854. Print 2019 Dec 1.
- Derived from this study: PubMed 29914796Souweidane MM, Kramer K, Pandit-Taskar N, Zhou Z, Haque S, Zanzonico P, Carrasquillo JA, Lyashchenko SK, Thakur SB, Donzelli M, Turner RS, Lewis JS, Cheung NV, Larson SM, Dunkel IJ. Convection-enhanced delivery for diffuse intrinsic pontine glioma: a single-centre, dose-escalation, phase 1 trial. Lancet Oncol. 2018 Aug;19(8):1040-1050. doi: 10.1016/S1470-2045(18)30322-X. Epub 2018 Jun 18.
- Derived from this study: PubMed 28686124Ivasyk I, Morgenstern PF, Wembacher-Schroeder E, Souweidane MM. Influence of an intratumoral cyst on drug distribution by convection-enhanced delivery: case report. J Neurosurg Pediatr. 2017 Sep;20(3):256-260. doi: 10.3171/2017.5.PEDS1774. Epub 2017 Jul 7.
- Derived from this study: PubMed 26939629Guisado DI, Singh R, Minkowitz S, Zhou Z, Haque S, Peck KK, Young RJ, Tsiouris AJ, Souweidane MM, Thakur SB. A Novel Methodology for Applying Multivoxel MR Spectroscopy to Evaluate Convection-Enhanced Drug Delivery in Diffuse Intrinsic Pontine Gliomas. AJNR Am J Neuroradiol. 2016 Jul;37(7):1367-73. doi: 10.3174/ajnr.A4713. Epub 2016 Mar 3.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Mark Souweidane, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radioactive iodine-labeled monoclonal antibody omburtamab and External Beam Radiotherapy in people with Brain Cancer and Brain Stem Glioma, run by Y-mAbs Therapeutics 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 6 inclusion and 9 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 19 Dec 2023. 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.
What does this 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.
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 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?
maximum tolerated dose (time frame: 2 years). The study lists 2 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 NCT01502917, which also lists 8 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 19 Dec 2023.