deltatrials
Active Not Recruiting INTERVENTIONAL NCT01864109

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

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

Sponsor: Memorial Sloan Kettering Cancer Center

Updated 24 times since 2017 Last updated: Apr 14, 2026 Started: May 1, 2013 Primary completion: May 1, 2027 Completion: May 1, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01864109, this observational or N/A phase trial focuses on Newly Diagnosed Ewing Sarcoma and remains ongoing. Sponsored by Memorial Sloan Kettering Cancer Center, it has been updated 24 times since 2013, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Jun 2019 · 7 months · monthly snapshot~Jun 2019 – ~Oct 2019 · 4 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Jul 2020 · 7 months · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2022 · 10 months · monthly snapshot~Jul 2022 – ~Jul 2023 · 12 months · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~Dec 2023 · 2 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Dec 2025 · 12 months · monthly snapshot~Dec 2025 – ~Apr 2026 · 5 months · monthly snapshotApr 18, 2026 – present · 3 months · daily API

Change History

24 versions recorded
  1. Apr 18, 2026 — Present [daily]

    Active Not Recruiting

    Phase: PHASE2None

  2. Dec 2025 — Apr 2026 [monthly]

    Active Not Recruiting PHASE2

  3. Dec 2024 — Dec 2025 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2

Show 19 earlier versions
  1. Dec 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  2. Oct 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

  3. Aug 2023 — Oct 2023 [monthly]

    Recruiting PHASE2

  4. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE2

  5. Jul 2022 — Jul 2023 [monthly]

    Recruiting PHASE2

  6. Sep 2021 — Jul 2022 [monthly]

    Recruiting PHASE2

  7. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  8. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  9. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

  10. Jul 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

  11. Dec 2019 — Jul 2020 [monthly]

    Recruiting PHASE2

  12. Oct 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  13. Jun 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  14. Nov 2018 — Jun 2019 [monthly]

    Recruiting PHASE2

  15. Sep 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  16. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  17. Aug 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  18. Feb 2017 — Aug 2017 [monthly]

    Recruiting PHASE2

  19. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

May 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Memorial Sloan Kettering Cancer Center
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .