Clinical Trial: 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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Desmo

Brief 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.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab [ Time Frame: 2 years ]
  In patients with measurable disease. added to the initial treatment of patients with Desmoplastic small round cell tumor (DSRCT)
• To estimate survival [ Time Frame: 2 years ]
  with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
• To estimate time to progression [ Time Frame: 2 years ]
  with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
• To assess use of 18FDG PET-CT [ Time Frame: 2 years ]
  as an early indicator of response in those patients with measurable or evaluable disease

Original Secondary Outcome:

• To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab [ Time Frame: 2 years ]
  added to the initial treatment of patients with Desmoplastic small round cell tumor (DSRCT)
• To estimate survival [ Time Frame: 2 years ]
  with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
• To estimate time to progression [ Time Frame: 2 years ]
  with the addition of irinotecan, temozolomide and bevacizumab to the initial treatment of patients with DSRCT
• To assess use of 18FDG PET-CT [ Time Frame: 2 years ]
  as an early indicator of response
• To assess an angiogenic profile [ Time Frame: 2 years ]
  in patients before, during and after therapy

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: August 25, 2010
Date Started: August 2010
Date Completion: August 2017
Last Updated: June 29, 2016
Last Verified: June 2016