Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
Public ClinicalTrials.gov record NCT01864109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial of Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to find out what effects, good and/or bad, the combination of irinotecan and temozolomide has on Ewing sarcoma. Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat pediatric patients at MSKCC. The investigators have used these two drugs for many years to treat patients with Ewing sarcoma whose cancer has relapsed. For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have their cancer cured by the chemotherapy and surgery/radiation therapy. This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT regimen. The investigators are trying to improve the success of standard therapy by adding these drugs. The use of irinotecan and temozolomide in this study is experimental because they have not been used before in patients with newly diagnosed Ewing sarcoma. However the investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma. It is not known if adding these two drugs will improve the outcomes of patients treated for Ewing sarcoma.
Study identification
- NCT ID
- NCT01864109
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Interventions
- Cyclophosphamide Drug
- Doxorubicin Device
- Vincristine Drug
- Ifosfamide Drug
- Etoposide Drug
- Surgery Procedure
- Radiation Therapy* Radiation
- Temozolomide Drug
- Irinotecan Drug
- Mesna Drug
- Dexrazoxane Drug
- G-CSF Drug
Drug · Device · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 1 Year to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2013 (Type not available)
- Primary completion
- May 2027 (Estimated)
- Completion
- May 2027 (Estimated)
- Last update posted
- Apr 17, 2026
2013 – 2027
United States locations
- U.S. sites
- 7
- U.S. states
- 2
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01864109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01864109 live on ClinicalTrials.gov.