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A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

Primary Purpose

Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
131 I-omburtamab
WAP-IMRT
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Desmoplastic Small Round Cell Tumor focused on measuring Solid Tumor, Peritoneal Solid Tumor, DSRC, I131-Omburtamab, Memorial Sloan Kettering Cancer Center, 19-182

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria for All Patients:

  • Age >1 year and able to cooperate with radiation safety restrictions during therapy period.
  • Minimum life expectancy of eight weeks as determined by consenting professional
  • Signed informed consent indicating awareness of the investigational nature of this program
  • Prior to intraperitoneal catheter placement

    • At least 1 weeks must have elapsed since prior chemotherapy
    • At least 2 weeks must have elapsed since prior-radiotherapy or biologic therapy
    • Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline

At the completion of surgery, patients must fulfill all of the additional following criteria:

Group A patients:

  • Have the diagnosis of DSRCT with peritoneal involvement, confirmed at MSK
  • Have undergone GTR of radiographically evident and visible/palpable disease, as per surgeon's report
  • Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement
  • Should not have had prior WAP IMRT
  • Should not have experienced progression of disease prior to enrollment
  • Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-omburtamab treatment. The minimum dose for hematopoietic stem cells is 2 x 10^6 CD34+ cells/kg

Group B patients:

  • Have the diagnosis of DSRCT with peritoneal involvement, confirmed at MSK
  • Have radiological evidence of disease (does not need to be in the abdomen) OR

Group C patients:

  • Have the diagnosis of tumors other than DSRCT, confirmed at MSK
  • Have a tumor that involves the peritoneum
  • Omburtamab reactivity must be confirmed by immunohistochemistry except for tumors with a reported incidence of B7H3 expression of >70%: these include neuroblastoma, melanoma, Ewing's family of tumors, rhabdomyosarcoma, osteosarcoma, Wilm's tumor, hepatoblastoma and rhabdoid tumor (testing for these histologies may be performed if desired at the discretion of the investigator and after discussion with the prinicipal investigator)
  • May or may not have radiological evidence of disease
  • <20% chance of long term disease-free survival

Exclusion Criteria:

  • Severe major organ toxicity. Cardiac, pulmonary, and neurologic toxicity should all be grade 1 or less; Renal, gastrointestinal and hepatic, toxicities should all be grade 2 or less (per NCI CTC version 5)
  • Platelet count should be >50,000/ul and hemoglobin should be >8gm/dl. Platelet transfusions are not permitted within one week for blood count demonstrating platelet count >50,000
  • 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 (defined as positive).
  • Active serious infections not controlled by antibiotics
  • Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
  • 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 and for 12 months following therapy. Pregnancy testing will be carried out within two weeks prior to administration of radioiodinated omburtamb in females of childbearing age.
  • Inability or unwillingness to comply with radiation safety procedures or protocol requirements.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently <500/ul despite use of G-CSF for >1 week, or if patients experience life threatening febrile neutropenia.

DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR

Participants with tumors other than DSRCT and will be enrolled onto an assessment arm to determine eligibility. Immunohistochemistry to assess B7H3 expression will be performed on frozen or paraffin embedded tissue using omburtamab (frozen tissue) or a commercially available anti-B7H3 antibody (if paraffin embedded).

Outcomes

Primary Outcome Measures

Progression Free Survival/PFS
Progression free survival after RIT + WA-IMRT.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2019
Last Updated
October 12, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Y-mAbs Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04022213
Brief Title
A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum
Official Title
Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Y-mAbs Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab. 131I-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. Researchers hope to learn more about how 131I-omburtamab works in the body, and how effective it is in treating cancer. 131I-Omburtamab is not approved by the FDA to treat DSRCT or other cancers of the peritoneum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma
Keywords
Solid Tumor, Peritoneal Solid Tumor, DSRC, I131-Omburtamab, Memorial Sloan Kettering Cancer Center, 19-182

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently <500/ul despite use of G-CSF for >1 week, or if patients experience life threatening febrile neutropenia.
Arm Title
Group B
Arm Type
Experimental
Arm Description
DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR
Arm Title
Group C
Arm Type
Experimental
Arm Description
Participants with tumors other than DSRCT and will be enrolled onto an assessment arm to determine eligibility. Immunohistochemistry to assess B7H3 expression will be performed on frozen or paraffin embedded tissue using omburtamab (frozen tissue) or a commercially available anti-B7H3 antibody (if paraffin embedded).
Intervention Type
Drug
Intervention Name(s)
131 I-omburtamab
Intervention Description
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
Intervention Type
Radiation
Intervention Name(s)
WAP-IMRT
Other Intervention Name(s)
Intensity Modulated Radiation Therapy
Intervention Description
Group A participants will receive WAP-IMRT approximately 2-4 weeks after completing IP RIT. A dose of 30 Gy will be delivered in 20 fractions of 1.5 Gy given once daily, 5 days per week over the course of approximately 4 weeks
Primary Outcome Measure Information:
Title
Progression Free Survival/PFS
Description
Progression free survival after RIT + WA-IMRT.
Time Frame
Up to 2 years after treatment is discontinued

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have the diagnosis of DSRCT confirmed at MSKCC Age >1 year and able to cooperate with radiation safety restrictions during therapy period. Prior to intraperitoneal catheter placement At least 1 weeks must have elapsed since prior chemotherapy At least 2 weeks must have elapsed since biologic therapy Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline At the completion of surgery, patients must fulfill all of the additional following criteria: Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement Exclusion Criteria: Prior progression of disease Prior hypothermic intraperitoneal chemotherapy (HIPEC) Cardiac, pulmonary, and neurologic toxicity should be grade 1 or less per NCI CTC version 5 Renal, gastrointestinal, and hepatic, toxicities should all be grade 2 of less (per NCI CTC version 5) History of allergy to mouse proteins Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Slotkin, MD
Phone
212-639-8856
Email
slotkine@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Neeta Pandit-Taskar, MD
Phone
212-639-3046
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Slotkin, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Slotkin, MD
Phone
212-639-8856

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

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