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NCT01864109 · ClinicalTrials.gov registry record · Phase 2
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
A Phase 2 study of Newly Diagnosed Ewing Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 7
- Study locations
NCT01864109: Active Phase 2 study of Newly Diagnosed Ewing Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01864109 is a Phase 2 study of Newly Diagnosed Ewing Sarcoma that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864109, a Phase 2 study of Newly Diagnosed Ewing Sarcoma, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
We will determine event free survival from the time of study entry for all patients. An event would include death from any cause, progression of tumor, recurrence of tumor, or second malignancy. Progressive disease (PD) will be defined according to RECIST 1.1.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Etoposide
- DRUG Vincristine
- DRUG Ifosfamide
- DEVICE Doxorubicin
Study Locations (7)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Cancer Center Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-05 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What the registry record for NCT01864109 still lists
NCT01864109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Newly Diagnosed Ewing Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01864109 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01864109 about?
NCT01864109 is a clinical study titled "Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma". 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 ...
What is the current status of trial NCT01864109?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2013-05. Estimated completion is 2027-05.
What conditions does trial NCT01864109 study?
This clinical trial studies the following conditions: Newly Diagnosed Ewing Sarcoma.
What interventions are being tested in trial NCT01864109?
The interventions under investigation include: Cyclophosphamide (DRUG), Etoposide (DRUG), Vincristine (DRUG), Ifosfamide (DRUG), Doxorubicin (DEVICE).
Who is sponsoring clinical trial NCT01864109?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01864109 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01864109's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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