Sarcoma Trial at National Cancer Institute

We wanted to pass on some information on behalf of Dr. Shivaani Kummar at the National Cancer Institute to inform you about a trial for which they are currently recruiting at the NIH - National Cancer Institute. The study is a randomized Phase II trial of Sunitnab vs. Cediranib Monotherapy to treat Alveolar Soft Part Sarcoma, with cross over at disease progression. A snapshot of basic information pertaining to the trial is below. If you have any questions or concerns, please contact:
NCI Referral Office: 1-888-NCI-1937 (ncicssc@mail.nih.gov)
or
Lauren Powell, Clinical Research Coordinator: 301-451-0992 (lauren.powell@nih.gov)


Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

Sponsored by: National Cancer Institute (NCI)

Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01391962

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.

Objective:
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 6 months in Part I and in Part II of the study for single-agent cediranib and single-agent sunitinib malate in patients with advanced ASPS.
Evaluate gene expression in tumor biopsies obtained at baseline and after treatment (at the Clinical Center, NCI only).

Eligibility:
· Patients age greater than or equal to 16 years with histologically or cytologically confirmed metastatic ASPS.

· 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.

Contact:
NCI Referral Office: 1-888-NCI-1937 (ncicssc@mail.nih.gov)
or
Lauren Powell, Clinical Research Coordinator: 301-451-0992 (lauren.powell@nih.gov)
Locations:
United States, Maryland- National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, MD.