Peritoneal CancerPhase 1NCT01099644
Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum
A Phase 1 study testing 131 I-8H9 in people with Peritoneal Cancer, run by Y-mAbs Therapeutics at 1 site in United States.
Trial summary
A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients >1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Peritoneal Cancer
- What is being tested?
- 131 I-8H9
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 11 Jun 2019
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have the diagnosis of (a) DSRCT with peritoneal involvement or (b) other Burtomab-positive solid tumors involving the peritoneum (e.g. adrenocortical carcinoma, Wilm's tumor).
- For tumors other than DSRCT, patients must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy or <20% chance of long term disease-free survival.
- For tumors other than DSRCT, Burtomab reactivity must be confirmed by immunohistochemistry.
- Patients with DSCRT are not required to have measurable or evaluable disease.
- Patients with tumors other than DSRCT without measurable or evaluable disease will only be considered if they have <20% chance of long term disease-free survival.
- Prior Therapy: At least 4 weeks should have elapsed since any biologic therapy, or immunotherapy. Three weeks should have elapsed since last dose of chemotherapy or radiotherapy.
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- Age >1 year and able to cooperate with radiation safety restrictions during therapy period.
- Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-Burtomab treatment. The minimum dose for hematopoietic stem cells is 2 x 106 CD34+ cells/kg.
- Minimum life expectancy of six weeks as determined by consenting professional.
- Signed informed consent indicating awareness of the investigational nature of this program.
Who cannot join
- Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 1 or less (per NCI CTC version 3 criteria) with the following exceptions: serum AST,ALT and alkaline phosphatase should be ≤5 x upper limit of normal (ULN), serum bilirubin ≤ 3 x ULN and nausea and vomiting should be ≤ grade 2 Patients with myelosuppression are not excluded if ANC ≥ 500/uL.
- Platelet count should be > 50,000/ul and hemoglobin should be > 8gm/dl. Patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels.
- Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution.
- History of allergy to mouse proteins.
- Patients previously treated with murine monoclonal antibodies will be excluded if they have a HAMA level of >1000U/ml.
- Active serious infections not controlled by antibiotics.
- Pregnant women and women who are breast feeding are excluded for fear of danger to the fetus/infant. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period. Pregnancy testing will be carried out within two weeks prior to administration of radioiodinated Burtomab in females of childbearing age.
- Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients >1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.
Read the detailed description
The purpose of this study is to test the safety of a new medicine called antibody 8H9 injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is an antibody or protein which binds to certain tumors, including DSCRT. There is a small number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might not benefit from this treatment. The investigators want to find out what effects, good and/or bad, it has.
This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at different dose levels. This is the first study using 131I-8H9 in the peritoneum.
- Conditions
- Peritoneal Cancer
- Being tested
- 131 I-8H9
- Keywords
- Peritoneum, Desmoplastic Small Round Cell Tumors, Intraperitoneal Radioimmunotherapy, 131 I-8H9, 09-090
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131 I-8H9Biological
Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible.
| Study group | Role | What they receive |
|---|---|---|
| 131 I-8H9 | Experimental | This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum. Receives: Biological: 131 I-8H9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the toxicity of 131I-8H9 administered intraperitoneally.
Assessment of toxicity of 131I-8H9 administered intraperitoneally.
Measured: weekly
Secondary outcomes (3)
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Assessment of maximal tolerated dose of 131I-8H9 administered intraperitoneally
Measured: 5 years
Assess pharmacokinetics for 131I-8H9 administered intraperitoneally
Assessment of the pharmacokinetics for IP 131I-8H9 administered intraperitoneally
Measured: 0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs.
Assess response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally
Assessment of the response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally
Measured: between days 24 and 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startApr 2010
- Primary completion11 Jun 2019
- Study completion11 Jun 2019
Why it stopped: Corporate business decision. Not due to safety or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Y-mAbs Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shakeel Modak, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099644
- Sponsor's protocol ID
- 09-090
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2010
- Last updated
- 31 Oct 2023
- Results posted
- No
- Individual data sharing
- No
Publications
Modak S, Zanzonico P, Grkovski M, Slotkin EK, Carrasquillo JA, Lyashchenko SK, Lewis JS, Cheung IY, Heaton T, LaQuaglia MP, Cheung NV, Pandit-Taskar N. B7H3-Directed Intraperitoneal Radioimmunotherapy With Radioiodinated Omburtamab for Desmoplastic Small Round Cell Tumor and Other Peritoneal Tumors: Results of a Phase I Study. J Clin Oncol. 2020 Dec 20;38(36):4283-4291. doi: 10.1200/JCO.20.01974. Epub 2020 Oct 29.
PubMed 33119478
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
- ClinicalTrials.gov ID
- NCT01099644
- Acronym / sponsor ID
- 09-090
- Conditions
- Peritoneal Cancer
- Keywords
- Peritoneum, Desmoplastic Small Round Cell Tumors, Intraperitoneal Radioimmunotherapy, 131 I-8H9, 09-090
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate business decision. Not due to safety or efficacy concerns
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Y-mAbs TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 7 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.
A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients >1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.
Detailed description
The purpose of this study is to test the safety of a new medicine called antibody 8H9 injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is an antibody or protein which binds to certain tumors, including DSCRT. There is a small number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might not benefit from this treatment. The investigators want to find out what effects, good and/or bad, it has.
This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at different dose levels. This is the first study using 131I-8H9 in the peritoneum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 131 I-8H9 | Experimental | Biological: 131 I-8H9This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have the diagnosis of (a) DSRCT with peritoneal involvement or (b) other Burtomab-positive solid tumors involving the peritoneum (e.g. adrenocortical carcinoma, Wilm's tumor).
- For tumors other than DSRCT, patients must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy or <20% chance of long term disease-free survival.
- For tumors other than DSRCT, Burtomab reactivity must be confirmed by immunohistochemistry.
- Patients with DSCRT are not required to have measurable or evaluable disease.
- Patients with tumors other than DSRCT without measurable or evaluable disease will only be considered if they have <20% chance of long term disease-free survival.
Key exclusion criteria (8 listed)
- Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 1 or less (per NCI CTC version 3 criteria) with the following exceptions: serum AST,ALT and alkaline phosphatase should be ≤5 x upper limit of normal (ULN), serum bilirubin ≤ 3 x ULN and nausea and vomiting should be ≤ grade 2 Patients with myelosuppression are not excluded if ANC ≥ 500/uL.
- Platelet count should be > 50,000/ul and hemoglobin should be > 8gm/dl. Patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels.
- Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution.
- History of allergy to mouse proteins.
- Patients previously treated with murine monoclonal antibodies will be excluded if they have a HAMA level of >1000U/ml.
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-8H9Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible. | Biological | 131 I-8H9 |
Primary outcome
Define the toxicity of 131I-8H9 administered intraperitoneally.
Time frame: weekly
Assessment of toxicity of 131I-8H9 administered intraperitoneally.
3 secondary outcomes
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Time frame: 5 years
Assess pharmacokinetics for 131I-8H9 administered intraperitoneally
Time frame: 0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs.
Assess response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally
Time frame: between days 24 and 38
Results and safety
The study was stopped early (reason given: Corporate business decision. Not due to safety or efficacy concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 33119478Modak S, Zanzonico P, Grkovski M, Slotkin EK, Carrasquillo JA, Lyashchenko SK, Lewis JS, Cheung IY, Heaton T, LaQuaglia MP, Cheung NV, Pandit-Taskar N. B7H3-Directed Intraperitoneal Radioimmunotherapy With Radioiodinated Omburtamab for Desmoplastic Small Round Cell Tumor and Other Peritoneal Tumors: Results of a Phase I Study. J Clin Oncol. 2020 Dec 20;38(36):4283-4291. doi: 10.1200/JCO.20.01974. Epub 2020 Oct 29.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Shakeel Modak, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 131 I-8H9 in people with Peritoneal Cancer, run by Y-mAbs Therapeutics 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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 31 Oct 2023. 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 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 was stopped early (reason given: Corporate business decision. Not due to safety or efficacy concerns). Results are not available in the source record.
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?
Define the toxicity of 131I-8H9 administered intraperitoneally. (time frame: weekly). 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 NCT01099644, which also lists 1 linked publication.
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 31 Oct 2023.