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

NCT01099644 | Terminated Phase 1

• 1 other identifier: 09-090
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Cancer

Keywords

Peritoneum; Desmoplastic Small Round Cell Tumors; Intraperitoneal Radioimmunotherapy; 131 I-8H9; 09-090

Outcome Measures

Primary Outcomes (1)

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

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

  weekly

Secondary Outcomes (3)

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

  5 years

• Assess pharmacokinetics for 131I-8H9 administered intraperitoneally

  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

  between days 24 and 38

Study Arms (1)

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.

Biological: 131 I-8H9

Interventions

131 I-8H9 BIOLOGICAL

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.

131 I-8H9

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Y-mAbs Therapeutics: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 33119478 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Shakeel Modak, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 7, 2010
• Study Start: April 1, 2010
• Primary Completion: June 11, 2019
• Study Completion: June 11, 2019
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)