← Back to Search

Irinotecan + Temozolomide for Ewing Sarcoma

Phase 2
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 Ewing sarcoma
Adequate renal function: Normal creatinine for age, Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is studying the use of two chemotherapy drugs, irinotecan and temozolomide, in patients with newly diagnosed Ewing sarcoma.

Who is the study for?
This trial is for patients aged 1 to 40 years with newly diagnosed, untreated Ewing sarcoma. They must have normal heart and kidney function, adequate liver function even if the tumor involves the liver, and sufficient blood cell counts. Participants need a central venous catheter and must agree to use contraception if of reproductive potential.Check my eligibility
What is being tested?
The study tests adding irinotecan and temozolomide (chemotherapy drugs) to the existing high-dose alkylator-based chemotherapy regimen (EFT), along with surgery/radiation as needed. This combination aims to improve outcomes in patients who are newly diagnosed with Ewing sarcoma.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts, fatigue, diarrhea from irinotecan specifically, and possible damage to organs like the heart or kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with Ewing sarcoma and have not received any treatment.
Select...
My kidney function tests are normal.
Select...
My liver tests are within the required limits.
Select...
I was diagnosed with my condition between the ages of 1 and 40.
Select...
My blood tests show normal white cell and platelet counts.
Select...
My heart is functioning well, as confirmed by heart tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

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 of patients with localized disease
Secondary outcome measures
adverse event profile
event free survival of patients with metastatic disease

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with metastatic diseaseExperimental Treatment12 Interventions
Patients will get 10 cycles of the combination intercalated between the final 4 cycles of standard chemotherapy. Cycles 4, 5, 7, 8, 10, 11, 13, 14, 16, and 17 will include: Irinotecan will be given on 10 days over weeks 1 and 2 of a cycle at a dose of 20 mg/m2/day intravenously Temozolomide will be given daily on the first 5 days of irinotecan administration at a dose of 100 mg/m2/day orally or intravenously Cycles 6, 9, and 12 will include: Ifosfamide 2,800 mg/m2/day on days 1-5 Etoposide 100 mg/m2/day on days 1-5 Cycle 15 will include: Cyclophosphamide will be given on days 1 and 2 at a dose of 2,100 mg/m2/day, or for patients < 10 years of age at a dose of 70 mg/kg/day Doxorubicin will be given on days 1 and 2 at a dose of 37.5 mg/m2/day Vincristine will be given on day 1 at a dose of 2 mg/m2 or 0.067 mg/kg (whichever is lower, to a max dose of 2 mg)
Group II: Patients with localized diseaseExperimental Treatment12 Interventions
Patients with localized disease will receive six cycles of the combination as "maintenance" therapy following standard chemotherapy. Cycles 4-6 will include: Ifosfamide 2,800 mg/m2/day on days 1-5 Etoposide 100 mg/m2/day on days 1-5 Cycle 7 will include : Cyclophosphamide will be given on days 1 and 2 at a dose of 2,100 mg/m2/day, or for patients < 10 years of age at a dose of 70 mg/kg/day Doxorubicin will be given on days 1 and 2 at a dose of 37.5 mg/m2/day Vincristine will be given on day 1 at a dose of 2 mg/m2 or 0.067 mg/kg (whichever is lower, to a max dose of 2 mg) Cycles 8-13 will include: Irinotecan will be given on 10 days over weeks 1 and 2 of a cycle at a dose of 20 mg/m2/day intravenously Temozolomide will be given daily on the first 5 days of irinotecan administration at a dose of 100 mg/m2/day orally or intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
2003
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Ifosfamide
2010
Completed Phase 4
~2980
Etoposide
2010
Completed Phase 3
~2440
Surgery
2000
Completed Phase 3
~2550
Temozolomide
2010
Completed Phase 3
~1930
Irinotecan
2017
Completed Phase 4
~2680
Mesna
2003
Completed Phase 2
~1380
Dexrazoxane
2016
Completed Phase 2
~80
G-CSF
2014
Completed Phase 4
~1610

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,539 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
24 Patients Enrolled for Ewing Sarcoma
Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
475 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
24 Patients Enrolled for Ewing Sarcoma
Paul Meyers, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
187 Total Patients Enrolled

Media Library

Surgery Clinical Trial Eligibility Overview. Trial Name: NCT01864109 — Phase 2
Ewing Sarcoma Research Study Groups: Patients with localized disease, Patients with metastatic disease
Ewing Sarcoma Clinical Trial 2023: Surgery Highlights & Side Effects. Trial Name: NCT01864109 — Phase 2
Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT01864109 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial recruiting participants below the age of eighteen?

"This medical experiment is seeking individuals between one year old and forty years of age."

Answered by AI

Who is capable of participating in this medical research?

"Currently, 93 individuals aged 1 to 40 with newly-diagnosed Ewing sarcoma are being sought after for this clinical trial. To qualify, they must have a creatinine level within the listed parameters; their absolute neutrophil count needs to be at least 1000/Kmcl and platelet count 100000/kmcl or more; total bilirubin should not outrun upper limit of normal (ULN) by 1.5 times; Alanine transaminase (AST) and aspartate aminotransferase (ALT) need to remain below ULN twice unless there is significant hepatic"

Answered by AI

How many individuals are participating in this research endeavor?

"Affirmative. According to information presented on clinicaltrials.gov, this experiment is actively searching for volunteers and has been since May 1st 2013. The trial is currently welcoming 93 people at 7 different medical sites with the last update having taken place June 1st 2022."

Answered by AI

What clinical conditions is Irinotecan regularly utilized for?

"Irinotecan is a chemotherapeutic agent and has been used to treat various malignancies, including Merkel cell cancer, leukemia, metastatic neoplasms, and prostate carcinoma."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to Irinotecan?

"Irinotecan's safety rating is 2, as this Phase 2 trial has data that suggests its safety but no evidence of efficacy."

Answered by AI

Is the recruitment of participants still open for this trial?

"Affirmative. According to clinicaltrials.gov, this research is presently enrolling participants who meet the inclusion criteria. First posted on May 1st 2013 and last updated June 1st 2022, it seeks 93 patients from 7 different sites for evaluation."

Answered by AI

How many geographical sites is the study conducted in?

"The trial is currently running in 7 locations, such as Memorial Sloan Kettering Bergen in Montvale and Memorial Sloan Kettering Westchester in Harrison. Additionally there are 4 other sites for this study, including the facility located at Commack."

Answered by AI

Can you provide information about prior Irinotecan trials?

"Irinotecan's first known clinical trial was launched at City of Hope Comprehensive Cancer Center in 1997. To date, there have been 2601 completed studies and 1516 are currently recruiting participants. Many research sites for this medication are located in Montvale, New jersey."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Bergen
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
2013. "Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01864109.
All > New York > New Jersey
~18 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top