Irinotecan, Temozolomide and Bevacizumab in Combination With Existing High Dose Alkylator Based C… (NCT01189643) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Irinotecan, Temozolomide and Bevacizumab in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Newly Diagnosed Patients With Desmoplastic Small Round Cell Tumor
United States15 participantsStarted 2010-08
Plain-language summary
This study adds irinotecan, temozolomide and bevacizumab to the chemotherapy regimen currently used to treat Desmoplastic small round cell tumor (DSRCT). The investigators are doing this study to find out what effects, good and/or bad, the combination of irinotecan, temozolomide and bevacizumab has on the patient and the DSRCT cancer.
Who can participate
Age range1 Year – 29 Years
SexALL
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Inclusion Criteria:
* Age greater than or equal to 1 year, less than 30 years
* Newly diagnosed, previously untreated patients with histologically or molecularly confirmed DSRCT
* Adequate hematologic function:
* Absolute neutrophil count ≥ 1,000/mm3
* Platelet count ≥ 100,000/mytm3
* Adequate renal function:
* Normal creatinine for age OR
* Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
* Adequate hepatic function:
* Total bilirubin ≤ 1.5 x the ULN for age
* AST ≤ 2.5 x the ULN for age \[in the absence of hepatic involvement of tumor\]
* 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
* Hypertension must be well controlled on stable doses of medication for at least two weeks prior to enrollment.
* 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
* Pregnant or breastfeeding females
* Patients with documented chronic non-healing wound, ulcer or bone fracture.
* Incomplete healing from previous oncologic or other major surgery.
* Surgical procedures:
Patients who have undergone major surgery (including open biopsy, thoracotomy, organ resection, exploratory laparotomy, arterio…