Overview

This trial is active, not recruiting.

Conditions sarcoma, desmoplastic small round cell tumor (dsrct)
Treatment irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator
Target VEGF
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Genentech, Inc.
Start date August 2010
End date August 2017
Trial size 15 participants
Trial identifier NCT01189643, 10-091

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator
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.

Primary Outcomes

Measure
To define the tolerability
time frame: 2 years
To define adverse event profile
time frame: 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 1 year up to 29 years old.

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

Additional Information

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
Principal investigator Heather Magnan, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in June 2016.