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Alkylating agents
Chemotherapy +/− Ganitumab for Ewing Sarcoma
Phase 3
Waitlist Available
Led By Steven G DuBois
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with bone metastasis meeting specified criteria
Patients with histologic diagnosis of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing how well combination chemotherapy works with or without the drug ganitumab in treating patients with newly diagnosed Ewing sarcoma.
Who is the study for?
This trial is for patients with newly diagnosed Ewing sarcoma that has spread, who haven't had prior chemotherapy or radiation. They must have a biopsy of the primary tumor and meet specific health criteria like normal kidney function, heart function, blood sugar levels, and liver enzymes. Pregnant or breastfeeding women are excluded, as well as those with diabetes or on long-term steroids.Check my eligibility
What is being tested?
The study is testing if adding ganitumab to standard combination chemotherapy (vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide) improves outcomes in metastatic Ewing sarcoma. Ganitumab targets the IGF-1R pathway which may help stop cancer growth. Patients are randomly assigned to receive either just chemo or chemo plus ganitumab.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from ganitumab; nausea; hair loss; mouth sores; low blood cell counts leading to increased infection risk and bleeding problems from chemotherapy drugs; heart damage from doxorubicin; and kidney damage from ifosfamide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to my bones.
Select...
I have been newly diagnosed with Ewing sarcoma or PNET with cancer spread to lungs, bones, or other areas.
Select...
My lung nodules are considered as spread cancer based on certain criteria.
Select...
My cancer has spread to my bone marrow, meeting specific conditions.
Select...
I have enough tumor tissue for testing.
Select...
My bilirubin levels are within the normal range for my age.
Select...
I have only had a biopsy of my tumor, no surgery to remove it.
Select...
My kidney function is normal or near normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free Survival
Secondary outcome measures
Frequency of Toxicity-events
Overall Survival
Other outcome measures
Circulating Tumor DNA (ctDNA) Testing
EWS Translocation
Frequency of Resolution of Bone Marrow Metastases
+8 moreSide effects data
From 2019 Phase 2 trial • 32 Patients • NCT0157370232%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Watering eyes
8%
Wheezing
8%
Urinary tract pain
8%
Myalgia
8%
Weight loss
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Sore throat
4%
Urinary tract infection
4%
Skin infection
4%
Lethargy
4%
Infusion site extravasation
4%
Urinary urgency
4%
Vomiting
4%
Insomnia
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib
Trial Design
2Treatment groups
Experimental Treatment
Group I: Regimen B (VDC/IE + ganitumab)Experimental Treatment12 Interventions
INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.
LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.
CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.
METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.
MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.
Group II: Regimen A (VDC/IE)Experimental Treatment11 Interventions
See Design Details.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin
2012
Completed Phase 3
~7940
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Etoposide
2010
Completed Phase 3
~2440
Etoposide Phosphate
2011
Completed Phase 2
~160
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Ganitumab
2009
Completed Phase 2
~260
Ifosfamide
2010
Completed Phase 4
~2980
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Vincristine
2003
Completed Phase 4
~2910
Vincristine Sulfate
2005
Completed Phase 3
~10110
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,841 Total Patients Enrolled
10 Trials studying Ewing Sarcoma
2,291 Patients Enrolled for Ewing Sarcoma
Steven G DuBoisPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer started in the soft tissues within the brain's protective layers.I have had chemotherapy or radiation therapy before.My cancer has spread to distant lymph nodes.My lung nodules are considered as spread cancer.I have enough tumor tissue available for testing.My baby's kidney function is normal, with creatinine ≤0.4 mg/dL.My liver enzyme levels are within the normal range, except I have liver cancer.My cancer has spread to my bones.I am sexually active and not using effective birth control.I have been newly diagnosed with Ewing sarcoma or PNET with cancer spread to lungs, bones, or other areas.My lung nodules are considered as spread cancer based on certain criteria.My cancer has spread to my bone marrow, meeting specific conditions.I have enough tumor tissue for testing.My bilirubin levels are within the normal range for my age.I have been diagnosed with Ewing sarcoma or PNET with cancer spread to lung, bone, or other areas.My cancer has spread only to the lymph nodes near the original tumor.I am a woman who can have children and do not have a negative pregnancy test result.My blood sugar levels are within the normal range for my age.My kidney function is good based on recent tests.I am on long-term steroid medication.I have only had a biopsy of my tumor, no surgery to remove it.My kidney function is normal or near normal.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen A (VDC/IE)
- Group 2: Regimen B (VDC/IE + ganitumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 sort of clinical trial been attempted before?
"Stereotactic Radiosurgery has been researched for over two decades. The first clinical trial occurred in 1997 and was sponsored by Alfacell. The study involved 300 participants. After the first trial, Stereotactic Radiosurgery received its Phase 3 drug approval. As of now, there are 1261 active studies being conducted for Stereotactic Radiosurgery across 2609 cities and 78 countries."
Answered by AI
What condition is Stereotactic Radiosurgery typically used to treat?
"Cancers such as Merkel cell cancer, leukemia, and prostate cancer can be treated using Stereotactic Radiosurgery."
Answered by AI
What are some similar cases in which Stereotactic Radiosurgery has been used?
"There are a total of 1261 clinical trials investigating Stereotactic Radiosurgery. Of these, 269 are currently ongoing and in Phase 3. The many studies for Stereotactic Radiosurgery are based in Philadelphia, Pennsylvania, but there are 46545 locations running trials for this treatment."
Answered by AI
How many people are helping test this new medical treatment?
"This study is not presently looking for more participants. According to the latest update on September 23rd, 2022, the study is not currently in need of subjects. If you are looking for other trials, 3433 studies related to bone and 1261 studies related to Stereotactic Radiosurgery are actively recruiting."
Answered by AI
What governing body has blessed the use of Stereotactic Radiosurgery?
"There is some data supporting Stereotactic Radiosurgery's efficacy, and as this is a Phase 3 trial, there is also evidence from multiple rounds of testing that confirm its safety--so we've given it a score of 3."
Answered by AI
What do researchers expect to find at the conclusion of this study?
"The primary outcome of this trial, which will be evaluated over approximately 5 years after enrollment is Event-free survival (EFS). Secondary outcomes include Sinusoidal obstructive disease (SOS) associated with the addition of ganitumab to VDC/IE which is defined as A phase where a patient experiences any SOS will be considered a phase with an SOS toxicity-event. The effect of possible correlations between analytic units that arises because some analytic units are contributed by the same individual will be explored. A random effects binomial model where a Normally distributed random effect with 0 mean and unknown variance chi-squared is contributed by each"
Answered by AI
Who else is applying?
What site did they apply to?
UCSF Medical Center-Parnassus
State University of New York Upstate Medical University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
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