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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 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. The trial reports 7 study locations across 2 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01864109
The ClinicalTrials.gov registry entry for NCT01864109 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 2 distinct geographic areas - top geographies include 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.
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