Clinical Trials /

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

NCT04022213

Description:

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.

Related Conditions:
  • Desmoplastic Small Round Cell Tumor
  • Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Hepatoblastoma
  • Malignant Solid Tumor
  • Melanoma
  • Neuroblastoma
  • Osteosarcoma
  • Rhabdoid Tumor
  • Rhabdomyosarcoma
  • Wilms Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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 Trial of 131 I-Omburtamab in Combination With External Beam Radiotherapy for Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum

Clinical Trial IDs

  • ORG STUDY ID: 19-182
  • NCT ID: NCT04022213

Conditions

  • Desmoplastic Small Round Cell Tumor
  • Peritoneal Cancer
  • Peritoneal Carcinoma

Interventions

DrugSynonymsArms
131 I-omburtamabGroup A

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalParticipants 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
  • 131 I-omburtamab
Group BExperimentalParticipants with DSRCT without GTR
  • 131 I-omburtamab
Group CExperimentalParticipants with tumors other than DSRCT who are B7H3-positive on immunohistochemistry
  • 131 I-omburtamab

Eligibility 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

        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 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:

          -  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:

          -  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:

          -  Prior therapy: Less than 4 weeks since any last chemotherapy, radiotherapy or biologic
             therapy

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival/PFS
Time Frame:Up to 2 years after treatment is discontinued
Safety Issue:
Description:Progression free survival after RIT + WA-IMRT.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Solid Tumor
  • Peritoneal Solid Tumor
  • DSRC
  • I131-Omburtamab
  • Memorial Sloan Kettering Cancer Center
  • 19-182

Last Updated

December 31, 2019