SarcomaEarly Phase 1NCT01189643
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
A Early Phase 1 study testing irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator in people with Sarcoma and Desmoplastic Small Round Cell Tumor (DSRCT), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 29 years
- Conditions the study is for
- Sarcoma, Desmoplastic Small Round Cell Tumor (DSRCT)
- What is being tested?
- irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Trial of 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
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.
- Being tested
- irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator
- Keywords
- BEVACIZUMAB (AVASTIN), IRINOTECAN (CPT-11) CAMPTOSAR, TEMOZOLOMIDE, DSRCT, 10-091
- Medical subject headings
- Sarcoma, Desmoplastic Small Round Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylatorDrug
Two cycles of the investigational combination irinotecan, temozolomide and bevacizumab- will be given followed by conventional chemotherapy with a modified P6 approach and surgical local control. Completion of modified P6 chemotherapy will be followed by a second-look surgery.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | This is a pilot study to evaluate the acute toxicities and activity of irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator based therapy in newly diagnosed patients with DSRCT. Receives: Drug: irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the tolerability
of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT
Measured: 2 years
To define adverse event profile
of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT
Measured: 2 years
Secondary outcomes (4)
To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab
In patients with measurable disease. added to the initial treatment of patients with Desmoplastic small round cell tumor (DSRCT)
Measured: 2 years
To estimate survival
with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
Measured: 2 years
To estimate time to progression
with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
Measured: 2 years
To assess use of 18FDG PET-CT
as an early indicator of response in those patients with measurable or evaluable disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Emily Slotkin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189643
- Sponsor's protocol ID
- 10-091
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2010
- Last updated
- 9 Sep 2026
- Results posted
- No