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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To define the tolerability | of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT | 2 years |
| To define adverse event profile | of irinotecan, temozolomide and bevacizumab in patients with newly diagnosed DSRCT | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years |
| To estimate survival |
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Inclusion Criteria:
Exclusion Criteria:
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
Screening with brain imaging is not required for asymptomatic patients. Proteinuria: Urine protein: creatinine ratio greater than or equal to 1.0
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| Name | Affiliation | Role |
|---|---|---|
| Emily Slotkin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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|
with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
| 2 years |
| To estimate time to progression | with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT | 2 years |
| To assess use of 18FDG PET-CT | as an early indicator of response in those patients with measurable or evaluable disease | 2 years |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D058405 | Desmoplastic Small Round Cell Tumor |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000077204 | Temozolomide |
| D000477 | Alkylating Agents |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D009676 | Noxae |
| D004786 | Toxic Actions |
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