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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04022213
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : December 8, 2022
Sponsor:
Collaborator:
Y-mAbs Therapeutics
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Desmoplastic Small Round Cell Tumor Peritoneal Cancer Peritoneal Carcinoma Drug: 131 I-omburtamab Radiation: WAP-IMRT Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of 131 I-Omburtamab in Combination With External Beam Radiotherapy for Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
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.
 Drug: 131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2

Radiation: WAP-IMRT
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
Other Name: Intensity Modulated Radiation Therapy
Experimental: Group B
DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR
 Drug: 131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2
Experimental: Group C
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).
 Drug: 131 I-omburtamab
Single dose of IP RIT administered through an IP catheter with 131 I-omburtamab at 80mCi/m2


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival/PFS [ Time Frame: Up to 2 years after treatment is discontinued ]
    Progression free survival after RIT + WA-IMRT.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022213


Contacts
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Contact: Emily Slotkin, MD 212-639-8856 slotkine@mskcc.org
Contact: Neeta Pandit-Taskar, MD 212-639-3046

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Emily Slotkin, MD    212-639-8856      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics
Investigators
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Principal Investigator: Emily Slotkin, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04022213    
Other Study ID Numbers: 19-182
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Solid Tumor
Peritoneal Solid Tumor
DSRC
 I131-Omburtamab
Memorial Sloan Kettering Cancer Center
19-182
Additional relevant MeSH terms:
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Desmoplastic Small Round Cell Tumor
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type