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Monoclonal Antibodies

Chemotherapy Combo for Desmoplastic Small Round Cell Tumor

Phase < 1
Waitlist Available
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
Newly diagnosed, previously untreated patients with histologically or molecularly confirmed DSRCT
Adequate renal function: Normal creatinine for age OR Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
Must not have
Prior chemotherapy or radiotherapy
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

This trial is testing a new combination of drugs to treat DSRCT, a rare and aggressive cancer. The goal is to see if the new combo is effective and has fewer side effects.

Who is the study for?
This trial is for young patients (1-30 years old) with a rare cancer called Desmoplastic Small Round Cell Tumor who haven't had previous cancer treatments. They need to have good blood counts, controlled blood pressure, and proper liver, heart, and kidney function. Participants must not be pregnant or breastfeeding and should agree to use contraception.
What is being tested?
The study tests adding irinotecan, temozolomide, and bevacizumab to the existing chemotherapy regimen for DSRCT. The goal is to assess the effects of this combination on both the patient's health and their response to the tumor treatment.
What are the potential side effects?
Possible side effects include increased risk of bleeding or wound healing complications due to bevacizumab; digestive issues from irinotecan; fatigue and potential immune system impacts from temozolomide; as well as general chemotherapy-related side effects like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with DSRCT and have not received any treatment.
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My kidney function is normal or nearly normal.
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My heart functions well, as confirmed by heart tests.
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I am between 1 and 29 years old.
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My blood tests show normal white cell and platelet counts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had chemotherapy or radiotherapy before.
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I do not have a bleeding disorder or significant blood clotting issues without taking blood thinners.
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I have not had a stroke or mini-stroke in the last 6 months.
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I do not have cancer that has spread to my brain or spinal cord.
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I have a chronic wound, ulcer, or bone fracture that hasn't healed.
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I have not had a blood clot in the last 3 months.
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My high blood pressure is not under control.
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I have had a severe hypertension crisis or brain issues due to high blood pressure.
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I have moderate to severe heart failure.
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I haven't had a heart attack or unstable chest pain in the last year.
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I have had a stroke or a transient ischemic attack.
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I am still recovering from recent major surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To define adverse event profile
To define the tolerability
Secondary study objectives
To assess use of 18FDG PET-CT
To estimate survival
To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ChemotherapyExperimental Treatment1 Intervention
This is a pilot study to evaluate the acute toxicities and activity of irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator based therapy in newly diagnosed patients with DSRCT.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,823 Total Patients Enrolled
70 Trials studying Sarcoma
13,816 Patients Enrolled for Sarcoma
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
570,041 Total Patients Enrolled
9 Trials studying Sarcoma
296 Patients Enrolled for Sarcoma
Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
543 Total Patients Enrolled
3 Trials studying Sarcoma
167 Patients Enrolled for Sarcoma
~1 spots leftby Aug 2025