New cocktail targets rare tumor in kids
NCT ID NCT01189643
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This early-phase trial adds three drugs—irinotecan, temozolomide, and bevacizumab—to the usual chemotherapy for newly diagnosed desmoplastic small round cell tumor (DSRCT), a rare and aggressive cancer. The study includes 15 patients aged 1 to 30 and aims to see if the combination is safe and tolerable. Researchers will also check how well the tumor responds and track survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- irinotecan, temozolomide, and bevacizumab (chemotherapy drugs)
- What this could lead to
- If it works, this could point toward a more effective treatment for desmoplastic small round cell tumor, a rare and aggressive cancer.
- What could go wrong
- This is a very early pilot trial with only 15 participants, so results may not apply to all patients. The added drugs may cause more side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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15 people
The number who actually took part.
- Started
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Aug 2010
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 29 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, arteriovenous grafts) \<28 days prior to enrollment will have bevacizumab dosing delayed as outlined in section 9.1 * Patients must be at least 48 hours from placement of central catheter before receiving first dose of bevacizumab * Minor surgical procedures (needle/laparoscopic core biopsies) for limited purposes of tissue retrieval will be allowed. Patients should not receive the first planned dose of bevacizumab until the wound is healed and 7 days have elapsed since the procedure. * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). * Thrombosis: * Patients must not have had a deep venous or arterial thrombosis (non-central venous catheter related) within the last three months prior to study entry. * Patients with cerebrovascular accident or transient ischemic attack within 6 months of therapy are excluded * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry. * CNS status: Patients must not have known CNS metastases or leptomeningeal disease. Screening with brain imaging is not required for asymptomatic patients. Proteinuria: Urine protein: creatinine ratio greater than or equal to 1.0 * Uncontrolled hypertension (defined as SBP and/or DBP \> 95th percentile for age) * Prior history of hypertensive crisis or hypertensive encephalopathy * NYHA Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 12 months prior to Day 1 * History of stroke or transient ischemic attack * Significant vascular (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 * History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 * Known hypersensitivity to any component of bevacizumab
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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