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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · May 28, 2013

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two chemotherapy drugs, irinotecan and temozolomide, when added to the standard treatment for newly diagnosed Ewing sarcoma, a type of bone cancer that primarily affects children and young adults. The current standard treatment, known as the EFT regimen, includes a combination of five chemotherapy drugs along with surgery and/or radiation therapy. This study aims to see if adding irinotecan and temozolomide can improve treatment outcomes for patients who may not respond fully to the standard care.

To be eligible for this trial, participants must be between 1 and 40 years old and have a confirmed diagnosis of Ewing sarcoma that has not been treated before. They should also meet specific health criteria, such as having good blood cell counts and normal kidney and liver function. Participants can expect to receive the experimental treatment while being closely monitored by healthcare professionals. It's important to note that this is a research study, so the effects of these drugs on newly diagnosed Ewing sarcoma patients are still being explored. If you or a loved one is considering participation, discussing it further with your healthcare team can provide more personalized information.

Gender

ALL

Eligibility criteria

• 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/K/mcl
• • Platelet count ≥ 100,000/Kmcl
• * 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
• • AST ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\]
• • ALT ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\]
• Normal cardiac function:
• • Shortening fraction ≥ 28% by echocardiogram OR
• • Left ventricular ejection fraction (LVEF) ≥ 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