← Back to Search

Radioactive Drug

I131-Omburtamab for Peritoneal Cancer

Phase 2

Recruiting

Led By Emily Slotkin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- 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

- 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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after treatment is discontinued

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of 131I-omburtamab, which may help prevent cancer from returning or spreading, but may also cause side effects. Researchers want to learn more about how the drug works in the body and how effective it is in treating cancer.

Who is the study for?

This trial is for people with a rare cancer called Desmoplastic Small Round Cell Tumor (DSRCT) or other cancers in the lining of the abdomen. Participants must not have active liver disease or disease outside the abdomen, be over 1 year old, and able to follow safety rules during treatment. They should not have had certain treatments recently and must meet specific health criteria including organ function.

What is being tested?

The study tests I131-Omburtamab's effects on preventing or delaying cancer return in DSRCT and peritoneal cancers. It's an investigational drug, meaning it isn't FDA-approved yet for these conditions. The trial also includes Whole Abdomen Intensity-Modulated Radiotherapy (WAP-IMRT), which is a precise radiation therapy technique.

What are the potential side effects?

Possible side effects of I131-Omburtamab may include allergic reactions due to mouse proteins, major organ toxicity affecting heart, lungs, nerves among others at varying degrees of severity; blood count issues like low platelets or hemoglobin; infections uncontrolled by antibiotics; hypersensitivity to iodine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have my stem cells stored for treatment after 131 I-omburtamab.

Select...

I don't have active cancer in my liver or beyond my abdomen, or it was fully removed.

Select...

I have not had WAP IMRT treatment before.

Select...

My cancer has spread to the lining of my abdomen.

Select...

I had surgery to remove all visible signs of my disease, according to my surgeon.

Select...

My tumor diagnosis, confirmed at MSK, is not DSRCT.

Select...

My DSRCT diagnosis with peritoneal involvement was confirmed at MSK.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not been treated with murine monoclonal antibodies or my HAMA level is below 1000U/ml.

Select...

I have a serious infection that antibiotics can't control.

Select...

My heart, lungs, and brain are mostly healthy; my kidneys, stomach, and liver are fairly healthy.

Select...

I have dense scar tissue in my abdomen that could affect treatment distribution.

Select...

My blood platelet count is above 50,000 and hemoglobin is above 8gm/dl.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after treatment is discontinued

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after treatment is discontinued

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after treatment is discontinued for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival/PFS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group CExperimental Treatment1 Intervention

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 II: Group BExperimental Treatment1 Intervention

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 III: Group AExperimental Treatment2 Interventions

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.

0 / 12Eligibility criteria met