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 range
1 Year – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.