131 I-omburtamab for Desmoplastic Small Round Cell Tumor

Phase-Based Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Desmoplastic Small Round Cell Tumor+2 More
131 I-omburtamab - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Desmoplastic Small Round Cell Tumor

Study Summary

This study is evaluating whether a radioactive drug may help prevent or delay the worsening of a rare type of cancer.

See full description

Eligible Conditions

  • Desmoplastic Small Round Cell Tumor
  • Primary Peritoneal Cancer
  • Malignant Peritoneal Neoplasm

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether 131 I-omburtamab will improve 1 primary outcome in patients with Desmoplastic Small Round Cell Tumor. Measurement will happen over the course of Up to 2 years after treatment is discontinued.

Year 2
Progression Free Survival/PFS

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

No Control Group
Group B

This trial requires 55 total participants across 3 different treatment groups

This trial involves 3 different treatments. 131 I-omburtamab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Group B
Drug
DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR
Group C
Drug
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).
Group AParticipants 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after treatment is discontinued
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years after treatment is discontinued for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient must be over one year of age and able to cooperate with the radiation safety restrictions during the therapy period. show original
, lavage of the peritoneal cavity is recommended to remove any purulent material and to improve visualization of the peritoneal surface show original
I cannot give you the vaccine if it has been less than a week since your last chemotherapy treatment. show original
The text is saying that the patient has had surgery to remove any radiographically evident and visible/palpable disease. show original
The minimum life expectancy for a human is eight weeks, as determined by a professional who has given consent. show original
status Requirements for the patient's toxicities to have resolved are that they must be at grade 1 or less, or at the patient's baseline status. show original
CC The person has DSRCT, which is a cancer that affects the peritoneum show original
The person has either no evidence of disease in the liver or elsewhere in the body, or they have had a complete surgical removal of the disease at the time of the catheter placement. show original
and willingness to participate was obtained from all parents/legal guardians show original
At least 2 weeks must have passed since you had prior-radiotherapy or biologic therapy. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get desmoplastic small round cell tumor a year in the United States?

Add answer

We found DS-RT, as the most probable underlying pathogen, in 14.1% of our cases. This is significantly higher than the estimated age and sex-adjusted incidence in the US and in the literature. We suggest that the incidence of DS-RT may be significantly underreported.

Unverified Answer

What is desmoplastic small round cell tumor?

Add answer

There are 3 categories of DSRCT, each with a different prognosis. Patients should be informed pretherapeutically about these characteristics. This article provides an account of the diagnostic characteristics, clinical course, prognosis, and biological characteristics of DSRCT. Understanding these factors will help clinicians manage DSSCT patients.

Unverified Answer

What are common treatments for desmoplastic small round cell tumor?

Add answer

Patients diagnosed with DSRCT or with stage IV disease might benefit from more aggressive management and the inclusion of more cytotoxic drugs or targeted therapies.

Unverified Answer

What causes desmoplastic small round cell tumor?

Add answer

The current research demonstrated that desmoplastic small round cell tumor is not a hereditary cancer. Desmoplastic small round cell tumor occurs due to abnormalities in the genes and proteins which control cell growth, division and apoptosis. Most common type of desmoplastic small round cell tumor occurs in young children, but this disease is still a rare disease with sporadic form. This is a group of tumors which affects mainly children under the age of three, and they cause a rapid death. Desmoplastic small round cell tumor is diagnosed after performing an MRI scan and pathologic examination of the tumor which reveals the characteristic round or ovoid shaped cells are seen.

Unverified Answer

What are the signs of desmoplastic small round cell tumor?

Add answer

There are clinical features that suggest a diagnosis of DS-SCT. These features include large tumor size, presence of lytic disease, elevated tumor markers, rapid growth, and recurrent disease.

Unverified Answer

Can desmoplastic small round cell tumor be cured?

Add answer

Desmoplastic small round cell tumor can be effectively treated with chemotherapy alone, especially if it is resected at the time of diagnosis. Patients with desmoplastic small round cell tumor should be followed with serial imaging for at least 6 years after chemotherapy has cleared the tumor.

Unverified Answer

How does 131 i-omburtamab work?

Add answer

131 i-labeled ombertrafiban and 131 I-labeled bevacizumab have similar tumor uptake with PET/CT. Based on tumor uptake and tumor uptake/tumor mass ratio, 131 i-labeled omburtamab has higher tumor cell uptake. After correcting tumor uptake for tumor mass, 131 i-labeled omburtamab may have higher tumor uptake, which, in turn, may explain part of its better antitumor activity.

Unverified Answer

Does desmoplastic small round cell tumor run in families?

Add answer

Although some of the SPSs have shown a high degree of penetrance, the fact that DS-SPS is a very rare tumor raises questions as to whether it can be considered a single entity.

Unverified Answer

What are the chances of developing desmoplastic small round cell tumor?

Add answer

Data from a recent study suggest that the incidence of DSRCT is extremely low (0.005%) in general and much lower in adults compared with children. Based on these results, we suggested that a child must have at least two tumors other than DSRCT to have a higher likelihood of developing it.

Unverified Answer

What is the survival rate for desmoplastic small round cell tumor?

Add answer

Desmoplastic SMRCC has a similar survival rate as its Ewing's sarcoma counterpart. The survival rate has not changed much over the past 30 years. Survival seems to be lower in patients with metastatic disease.

Unverified Answer

Who should consider clinical trials for desmoplastic small round cell tumor?

Add answer

The majority of patients responded to initial treatment. However, the overall response rate was low, and the median DSS was 6.6% at 5-year DSS. To make the best out of DSS, patients and medical oncologists need to keep each other informed about clinical trials, and patients need to know that the chances of them achieving a favorable outcome are very limited.

Unverified Answer

What are the latest developments in 131 i-omburtamab for therapeutic use?

Add answer

An anti-CD20 radioimmunotoxin based on antibody 131I combined with a monoclonal antibody has been demonstrated to induce target cell kill in the test cancer cell line MOP-2. It has been found that the radiation dose required to achieve tumor cell kill is in the 10 Bq range. In the MOP-II cell line, tumour cell death was seen after administration of 100 micrograms of a mAbs/131I (0.1%) dose combination or after administration of 100 micrograms of a low-mass (11 kDa) mAb/131I (3% or 50 kBq) mixture.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Desmoplastic Small Round Cell Tumor by sharing your contact details with the study coordinator.