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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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.

0 / 17Eligibility criteria met