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TerminatedNCT01099644Updated Oct 31, 2023

Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum

A Phase 1 interventional study of 131 I-8H9 in Peritoneal Cancer, sponsored by Y-mAbs Therapeutics. Terminated at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Y-mAbs Therapeutics · Phase 1, Interventional, and Treatment

Why this study was terminated
Corporate business decision. Not due to safety or efficacy concerns
Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
1 Year and older
Sex
All
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Study 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 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.

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Conditions studied

  • Peritoneal Cancer

Keywords

  • Peritoneum
  • Desmoplastic Small Round Cell Tumors
  • Intraperitoneal Radioimmunotherapy
  • 131 I-8H9
  • 09-090
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In context

Desmoplastic Small Round Cell Tumor

47 studies on the registry are indexed under Desmoplastic Small Round Cell Tumor; 14 are open to participants now.

This study's enrollment of 54 is above the median of 31 across 39 interventional studies indexed under Desmoplastic Small Round Cell Tumor.

Browse Desmoplastic Small Round Cell Tumor studies →

Lead sponsor

Y-mAbs Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    131 I-8H9

    This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.

    Biological: 131 I-8H9

Interventions

  • Biological131 I-8H9

    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.

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What researchers measure

Primary outcomes

  1. Define the toxicity of 131I-8H9 administered intraperitoneally.

    Assessment of toxicity of 131I-8H9 administered intraperitoneally.

    Time frame: weekly

Secondary outcomes

  1. Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally

    Assessment of maximal tolerated dose of 131I-8H9 administered intraperitoneally

    Time frame: 5 years

  2. Assess pharmacokinetics for 131I-8H9 administered intraperitoneally

    Assessment of the pharmacokinetics for IP 131I-8H9 administered intraperitoneally

    Time frame: 0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs.

  3. 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

    Time frame: between days 24 and 38

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Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01099644
Lead sponsor
Y-mAbs Therapeutics
Responsible party
Sponsor
First posted
Apr 7, 2010
Start date
Apr 2010
Primary completion
Jun 11, 2019
Completion
Jun 11, 2019
Last update
Oct 31, 2023

Study contacts

Shakeel Modak, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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