Clinical Trial: Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Cediranib (AZD2171) in Patients With Alveolar Soft Part Sarcoma

Brief Summary:

Background:

  • Alveolar soft part sarcoma is a type of cancer that develops in tissues that connect, support, or surround other organs in the body. It relies heavily on new blood vessels to grow and spread through the body. There is no effective systemic treatment for patients with alveolar soft part sarcoma.
  • The drug AZD2171 (cediranib) is an experimental drug, not yet approved by the Food and Drug Administration. The drug blocks the creation of new blood vessels. The drug has had initial clinical trials, and researchers are interested in determining whether cediranib is effective in inhibiting tumor growth in individuals who have alveolar soft part sarcoma.

Objectives:

- To find out whether AZD2171 works in patients who have alveolar soft part sarcoma.

Eligibility:

- Individuals 18 years of age and older who have been diagnosed with alveolar soft part sarcoma.

Design:

  • After an initial screening visit, patients will take AZD2171 by mouth once a day, every day for the duration of the study. The treatment will be given in 28-day cycles.
  • Patients will keep a study diary to record the doses taken, any missed doses, and any side effects.
  • Patients will have the following tests and procedures during the treatment period: clinic visit with physical examination every 2 weeks, regular blood pressure monitoring, blood and urine tests, heart function tests, imagining scans to evaluate tumor size and response to the tre

    Detailed Summary:

    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), a VEGF/KIT tyrosine kinase inhibitor, has recently demonstrated antitumor activity in early phase clinical trials, which included 7 adult and 3 pediatric patients with ASPS.

    Objectives:

    Adult patients:

    To determine the response rate (PR + CR) of AZD2171 in adult patients with ASPS.

    To compare gene expression profiles between pre-treatment and post-treatment biopsy specimens.

    Pediatric patients:

    To determine if pediatric patients with ASPS will experience at least a minimal response rate when treated with AZD2171

    Eligibility:

    Patients must have histologically or cytologically confirmed metastatic alveolar soft part sarcoma.

    Less than 16 years old. BSA must be greater than or equal to 1.04 m2 and subject must be able to swallow tablets.

    Adequate organ function.

    Design:

    Adult patients will be treated with AZD2171 at 30 mg by mouth once a day for 28 days (28-day cycles). Pediatric patients (< 16 years old) will be treated with 12 mg/m2/day once a day for 28 day (28-day
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome: To determine if pediatric patients with ASPS will experience at least a minimal response rate when treated with AZD2171 [ Time Frame: 2 cycles ]

    Original Primary Outcome: To determine the response rate (PR + CR) of AZD2171 in patients with ASPS.

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: July 18, 2009
    Date Started: July 15, 2009
    Date Completion: July 31, 2017
    Last Updated: May 12, 2017
    Last Verified: May 4, 2017