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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants
Secondary outcome measures
Local Failure Rate
Overall Survival
Progression-free Survival
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of Tennessee Health Science CenterOTHER
48 Previous Clinical Trials
25,080 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
429 Previous Clinical Trials
5,306,734 Total Patients Enrolled
1 Trials studying Desmoplastic Small Round Cell Tumor
32 Patients Enrolled for Desmoplastic Small Round Cell Tumor
University of TennesseeOTHER
190 Previous Clinical Trials
144,005 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am newly diagnosed with a specific type of abdominal cancer that cannot be surgically removed or has spread.I had cancer before, but it wasn't skin cancer or it's been 5 years since my skin cancer was treated and I'm in remission without having had chemo, immunotherapy, or radiation.I am newly diagnosed with Ewing sarcoma, and it has spread or is in my pelvis, or I was 14 or older when diagnosed.My liver is functioning well, with bilirubin levels at or below 3.0 mg/dL.I am not taking strong medications or substances that affect liver enzymes.I have not had emergency radiation therapy.My blood sugar levels are within the normal range.My blood tests show enough neutrophils and platelets, and I haven't had a transfusion in the last week.I am in Group B and will receive initial window therapy.I am 25 years old or younger.My liver tests are within normal range for my age.I haven't had chemotherapy or radiation, except to save a vital organ's function.My heart's pumping ability is good.I am willing to use birth control to prevent pregnancy during the trial.I was diagnosed with Ewing sarcoma in my bones or soft tissue before turning 14.My kidney function is appropriate for my age.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (Standard Risk)
- Group 2: Group B (High Risk)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this research ever been conducted before?
"Alfacell kickstarted the research of Group A (Standard Risk) in 1997, with an initial trial involving 300 participants. Subsequent Phase 3 testing soon led to its approval for drug use across a multitude of cities and countries - currently there are 1706 active studies taking place."
Answered by AI
How many individuals have enrolled in this clinical experiment?
"Currently, this clinical trial is not enrolling any new participants. However, if you are searching for other studies, there are 2764 trials recruiting patients with desmoplastic small round cell tumor and 1706 Standard Risk (Group A) studies that remain open to enrolment. This particular study was initially published on December 27th 2013, with its most recent update made July 29th 2022."
Answered by AI
What medical conditions typically require therapy under Group A (Standard Risk)?
"Group A (Standard Risk) is an effective tool for treating lung cancer, sclc progression, and neuroblastoma."
Answered by AI
Are there any existing research trials exploring the efficacy of Group A (Standard Risk) therapies?
"Currently, 1706 trials related to Standard Risk Group A are proceeding with 368 of them entering Phase 3. Most of these occur in the Maryland city of Bethesda but there are 6350 other sites executing investigations for this group."
Answered by AI
Is Group A (Standard Risk) a secure option for individuals?
"From the data collected from this Phase 2 trial, Group A (Standard Risk) was assigned an overall safety rating of 2 on a scale of 1 to 3. This is because while there are some studies that indicate its safety, no evidence exists supporting efficacy yet."
Answered by AI
Are researchers still recruiting participants for this investigation?
"At the moment, this clinical trial is not enlisting participants. First posted on December 27th 2013 and last updated July 29th 2022, those searching for other studies can find 2,764 trials recruiting patients with desmoplastic small round cell tumors and 1,706 Group A (Standard Risk) studies actively admitting individuals."
Answered by AI
Who else is applying?
What site did they apply to?
St. Jude Children's Research Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
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