Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum (NCT01099644) | Clinical Trial Compass
TerminatedPhase 1
Intraperitoneal RIT With 131I-8H9 for Pts With DSRCT and Other Solid Tumors Involving the Peritoneum
Stopped: Corporate business decision. Not due to safety or efficacy concerns
United States54 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
What they're measuring
1
Define the toxicity of 131I-8H9 administered intraperitoneally.