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Status: RecruitingPhase: Phase 2Diagnosis: Pediatric Sarcoma, SarcomaNCT ID: NCT01391962
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-044
Background: - Alveolar soft part sarcoma (ASPS) is a rare, highly vascular tumor accounting for less than 1% of soft tissue sarcomas. There is no effective systemic treatment for patients with metastatic ASPS. Little is known with regards to relevant molecular markers as potential therapeutic targets. - Cediranib (AZD2171) and sunitinib (SU011248), oral small molecule inhibitors of VEGF receptor tyrosine kinases, are showing preliminary evidence of activity in patients with ASPS. Objectives: - Part I: Determine the objective response rate (ORR) of single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. - Part II: Determine the ORR of cediranib in patients who progress on the sunitinib arm, and determine the ORR of sunitinib in patients who progress on the cediranib arm. - Determine the progression-free survival (PFS) at 24 weeks for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS. Eligibility: - Patients aged greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS. - Patients must show evidence of objective disease progression per RECIST 1 on scans within the 3-month period immediately preceding enrollment. Both scans used to determine disease progression should have been obtained within this 6-month period. - Patients with newly diagnosed, unresectable, measurable, metastatic ASPS who show clinical evidence of disease progression will be eligible. - Patients must not have received treatment with any VEGF receptor tyrosine kinase inhibitor (e.g., cediranib, sunitinib, pazopanib, sorafenib); however, prior treatment with bevacizumab is allowed. Design: - Part I: Patients will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day in 28-day cycles. - Part II: At the time of disease progression, patients will cross over to the other treatment arm after a 2-week wash-out period. - Appropriate anatomic imaging studies will be performed at baseline and every 2 cycles for restaging. - The study will be conducted using an optimal two-stage design to rule out an unacceptably low 15% clinical response rate (PR+CR) in favor of a modestly high response rate of 40%. The study will initially enroll 10 evaluable patients in each arm. If 0 or 1 of the 10 patients has a clinical response, then no further patients will be accrued. If 2 or more the first 10 patients have a response, then accrual continues to a total of 22 patients in each arm.
Conducting Institutions: Dana-Farber Cancer Institute, Children's Hospital Boston, Brigham and Women's Hospital
Overall PI: Carlos Rodriguez-Galindo, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Suzanne George, MD,
Dana-Farber Cancer Institute
Contacts: Dana-Farber Cancer Institute:
email@example.comDana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
firstname.lastname@example.orgDana-Farber Cancer Institute: