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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

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ClinicalTrials.gov Identifier: NCT04022213
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Y-mAbs Therapeutics, Inc
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to determine if treatment with the investigational drug 131I-Omburtamab can prevent or delay the worsening of Desmoplastic Small Round Cell Tumors/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: WA-IMRT Phase 2

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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


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
Drug: 131 I-omburtamab
Single dose of IP RIT with 131 I-omburtamab at 80mCi/m2

Radiation: WA-IMRT
Group A participants will receive WA-IMRT 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
Participants with DSRCT without GTR
Drug: 131 I-omburtamab
Single dose of IP RIT with 131 I-omburtamab at 80mCi/m2

Experimental: Group C
Participants with tumors other than DSRCT who are B7H3-positive on immunohistochemistry
Drug: 131 I-omburtamab
Single dose of IP RIT with 131 I-omburtamab at 80mCi/m2




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.



Information from the National Library of Medicine

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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
  • Prior Therapy: At least 4 weeks should have elapsed since last chemotherapy, radiotherapy or biologic therapy
  • Signed informed consent indicating awareness of the investigational nature of this program

Group A patients must fulfill all of the additional following criteria:

  • Have the diagnosis of DSRCT with peritoneal involvement, confirmed at MSK
  • Have undergone GTR of abdomino-pelvic disease, as per surgeon's report
  • Have no definitive radiological evidence of disease in liver or outside the abdomen/pelvic
  • Should not have had prior WA-IMRT
  • 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 must fulfill all of the additional following criteria:

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

Group C patients must fulfill all of the additional following criteria

  • 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
  • May or may not have radiological evidence of disease
  • Hav a history of tumor progression or recurrence or failure to achieve complete remission after standard therapy
  • <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
  • Active serious infections not controlled by antibiotics
  • Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
  • Patients who have received live viral vaccines within 30 days before the first dose of study treatment (patients are NOT permitted to receive viral vaccines while participating in the study)
  • 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.

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: Shakeel Modak, MD 212-639-7623 modaks@mskcc.org
Contact: Emily Slotkin, MD 212-639-8856 slotkine@mskcc.org

Locations
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United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Shakeel Modak, MD    212-639-7623      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Y-mAbs Therapeutics, Inc
Investigators
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Principal Investigator: Shakeel Modak, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04022213     History of Changes
Other Study ID Numbers: 19-182
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
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