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
- Are there results?
- Not yet: the study is under way
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:
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- 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
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- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01189643
- Acronym / sponsor ID
- 10-091
- Keywords
- BEVACIZUMAB (AVASTIN), IRINOTECAN (CPT-11) CAMPTOSAR, TEMOZOLOMIDE, DSRCT, 10-091
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2010 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylatorThis 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. |
Who may qualify
- Ages
- 1 year to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylatorTwo 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. | Drug | Chemotherapy |
Primary outcome
To define the tolerability
Time frame: 2 years
of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT
To define adverse event profile
Time frame: 2 years
of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT
4 secondary outcomes
To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab
Time frame: 2 years
To estimate survival
Time frame: 2 years
To estimate time to progression
Time frame: 2 years
To assess use of 18FDG PET-CT
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Slotkin, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the tolerability (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.