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

This study is currently recruiting participants.
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01864109
First received: May 23, 2013
Last updated: March 19, 2014
Last verified: March 2014

May 23, 2013
March 19, 2014
May 2013
May 2019   (final data collection date for primary outcome measure)
event free survival of patients with localized disease [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01864109 on ClinicalTrials.gov Archive Site
  • event free survival of patients with metastatic disease [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    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.

  • adverse event profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicities are graded by the Common Toxicity Criteria (Version 4.0) developed by the National Cancer Institute (NCI) of the USA.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Newly Diagnosed Ewing Sarcoma
  • Drug: Cyclophosphamide
  • Device: Doxorubicin
  • Drug: Vincristine
  • Device: Ifosfamide
  • Drug: Etoposide
  • Procedure: Surgery
  • Radiation: Radiation Therapy*
    If local control includes RT, RT should be given concurrently with chemotherapy cycles
  • Experimental: Patients with localized disease
    Patients with localized disease will receive six cycles of the combination as "maintenance" therapy following standard chemotherapy.
    Interventions:
    • Drug: Cyclophosphamide
    • Device: Doxorubicin
    • Drug: Vincristine
    • Device: Ifosfamide
    • Drug: Etoposide
    • Procedure: Surgery
    • Radiation: Radiation Therapy*
  • Experimental: Patients with metastatic disease
    Patients with metastatic disease will receive ten cycles of the combination intercalated between the final 4 cycles of standard chemotherapy.
    Interventions:
    • Drug: Cyclophosphamide
    • Device: Doxorubicin
    • Drug: Vincristine
    • Device: Ifosfamide
    • Drug: Etoposide
    • Procedure: Surgery
    • Radiation: Radiation Therapy*
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
83
May 2019
May 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than or equal to one year and less than or equal to 40 years at the time of diagnosis
  • Newly diagnosed, previously untreated patients with histologically or molecularly confirmed Ewing sarcoma
  • Adequate hematologic function:

    • Absolute neutrophil count ≥ 1,000/μL
    • Platelet count ≥ 100,000/μL
  • Adequate renal function:

    • Normal creatinine for age (See table below) OR
    • Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 Age(Years) Maximum Serum Creatinine (mg/dL) ≤ 5 0.8 6 to ≤ 10 1 11 to ≤ 15 1.2 ≥ 16 1.5

Adequate hepatic function:

  • Total bilirubin ≤ 1.5 x the ULN for age
  • AST ≤ 2.5 x the ULN for age [in the absence of hepatic involvement of tumor]
  • ALT ≤ 2.5 x the ULN for age [in the absence of hepatic involvement of tumor]

Normal cardiac function:

  • Shortening fraction greater than or equal to 28% by echocardiogram OR
  • Left ventricular ejection fraction (LVEF) greater than or equal to 50% on technetium- 99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram

    • Patients must consent to an indwelling central venous catheter.
    • Sexually active patients of reproductive potential must be willing to use an effective method of contraception.

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway)
  • Pregnant or breastfeeding females
Both
1 Year to 40 Years
No
Contact: Heather Magnan, MD 212-639-7937
Contact: Paul Meyers, MD 212-639-5952
United States
 
NCT01864109
13-068
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Heather Magnan, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP