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Alkylating agents

Chemotherapy + Targeted Therapy for Ewing Sarcoma

Phase 2

Waitlist Available

Led By Sara M. Federico, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

OR Group B participants must be newly diagnosed with intra-abdominal, unresectable or metastatic desmoplastic small round cell tumor. Metastatic site must be biopsy proven.

Group B participants must have newly diagnosed of histologically proven ESFT involving the bone or soft tissue and at least one of the following: metastatic disease (must be biopsy proven), or pelvic primary, or ≥14 years of age at the time of diagnosis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 weeks after start of therapy (after 2 initial courses)

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial will study two different treatments for Ewing sarcoma family of tumors (ESFT) and desmoplastic small round cell tumor (DSRCT).

Who is the study for?

This trial is for children under 14 with non-pelvic ESFT and young adults up to 25 years old with high-risk ESFT or DSRCT, including those with metastatic disease, pelvic tumors, or intra-abdominal DSRCT. Participants must have proper organ function and no prior cancer treatments (except emergency radiation). They should not be pregnant/breastfeeding and must agree to use birth control.

What is being tested?

The study tests standard treatment in Group A (standard risk) children under 14 without pelvic tumors or spread of the disease. Group B (high risk), older than 14, with pelvic tumors or metastasis receive more aggressive therapy. Treatments include chemotherapy drugs like vincristine and doxorubicin, targeted therapies such as temsirolimus and sorafenib, surgery, radiation, plus long-term follow-up.

What are the potential side effects?

Possible side effects from treatments may include hair loss, nausea/vomiting from chemotherapy; increased bleeding/infection risks due to bone marrow suppression; kidney/liver damage; heart problems; fatigue; mouth sores. Targeted therapies might cause skin reactions, blood pressure changes & wound healing complications.

Eligibility Criteria

Inclusion Criteria

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

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I am newly diagnosed with a specific type of abdominal cancer that cannot be surgically removed or has spread.

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I am newly diagnosed with Ewing sarcoma, and it has spread or is in my pelvis, or I was 14 or older when diagnosed.

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My liver is functioning well, with bilirubin levels at or below 3.0 mg/dL.

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I am not taking strong medications or substances that affect liver enzymes.

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I have not had emergency radiation therapy.

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I am 25 years old or younger.

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My liver tests are within normal range for my age.

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My heart's pumping ability is good.

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I was diagnosed with Ewing sarcoma in my bones or soft tissue before turning 14.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 weeks after start of therapy (after 2 initial courses)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 weeks after start of therapy (after 2 initial courses)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks after start of therapy (after 2 initial courses) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants

Secondary study objectives

Local Failure Rate

Overall Survival

Progression-free Survival

+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.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Group A (Standard Risk)Active Control7 Interventions

Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m\^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.

Group II: Group B (High Risk)Active Control10 Interventions

Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide, irinotecan, temozolomide, temsirolimus, bevacizumab, and sorafenib. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone or surgery followed by radiation.

0 / 9Eligibility criteria met