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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2024
  • participants needed
    55
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 14 June 2022
cancer
cancer chemotherapy
tumor progression
desmoplastic

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.

Details
Condition Desmoplastic Small Round Cell Tumor, Peritoneal Cancer, Peritoneal Carcinoma
Treatment 131 I-omburtamab, WA-IMRT, WAP-IMRT
Clinical Study IdentifierNCT04022213
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

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
Group B patients
Should not have experienced progression of disease prior to enrollment
Have the diagnosis of DSRCT with peritoneal involvement, confirmed at MSK
Stem cells: Patients must have an autologous hematopoietic stem cell product
Group C patients
cryopreserved and available for re-infusion after 131 I-omburtamab treatment. The
Have radiological evidence of disease (does not need to be in the abdomen) OR
minimum dose for hematopoietic stem cells is 2 x 10^6 CD34+ cells/kg
Have the diagnosis of tumors other than DSRCT, confirmed at MSK
Have a tumor that involves the peritoneum
May or may not have radiological evidence of disease
<20% chance of long term disease-free survival
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)

Exclusion Criteria

History of allergy to mouse proteins
Active serious infections not controlled by antibiotics
Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
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
Patients previously treated with murine monoclonal antibodies will be excluded if they
have a HAMA level of >1000U/ml (defined as positive)
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
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