Clinical trial · Interventional
Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum
Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
NCT01099644CI-TRIAL-00070940terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Corporate business decision. Not due to safety or efficacy concerns
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131 I-8H9 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 131 I-8H9
- description
- This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.
- interventionNames
- Biological: 131 I-8H9
Primary outcomes (1)
- measure
- Define the toxicity of 131I-8H9 administered intraperitoneally.
- timeFrame
- weekly
- description
- Assessment of toxicity of 131I-8H9 administered intraperitoneally.
Secondary outcomes (3)
- measure
- Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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: * 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.
References
Publications (1)
- DERIVEDModak 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. PMID 33119478