Clinical Trial: A Phase 2 Study of Anti-PD-L1 Antibody Atezolizumab in Alveolar Soft Part Sarcoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2 Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma
Brief Summary:
Background:
Sometimes the cancer advanced alveolar soft part sarcoma (ASPS) cannot be helped with surgery or other treatment. The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have side effects. Researchers want to study if the drug will shrink a tumor in people with advanced ASPS.
Objective:
To test good and bad effects of the drug atezolizumab.
Eligibility:
People at least 6 years old with ASPS that cannot be cured with surgery
Design:
Participants will be screened with heart and pregnancy tests. Some may have scans or other tests.
At the study start, participants will have:
- Medical history
- Physical exam
- Heart, blood, and pregnancy tests
- Scan to measure tumor
- Optional tumor sample taken
Each study cycle is 21 days.
In cycle 1:
- On day 1, participants will have blood tests. They will get the study drug in a vein for about 1 hour. They will be observed for a few hours after.
- On days 8 and 15, participants will have blood tests.
In o
Detailed Summary:
Background:
- Alveolar soft part sarcoma (ASPS) is a rare, indolent disease with a poor prognosis that occurs most frequently in patients between 15 and 35 years of age. The tumors are slow-growing, painless masses involving almost every part of the body but predominantly in the trunk and proximal extremities; metastatic disease is frequently observed at presentation.
- Atezolizumab is a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1) with potential immune checkpoint inhibitory and antineoplastic activities. An adolescent with ASPS who received atezolizumab under an individual-patient IND had a marked response, including complete resolution of a large brain lesion.
Objectives:
- Determine the objective response rate (ORR) of atezolizumab in patients with advanced ASPS in adult subjects greater than or equal to 18 years and in pediatric/adolescent subjects greater than or equal to 6 years
- Determine duration of response (DOR) using RECIST v 1.1 and/or change in clinical symptoms
- Measure PFS time as determined by investigator using RECIST v 1.1
- At the Clinical Center, NCI, only: correlate response with expression of potential immune biomarkers in paired biopsies
- Compare the RECIST v 1.1 vs the immune-related response criteria (irRC) in patients with ASPS on atezolizumab
Eligibility:
-Patients greater than or equal to 6 years of age with histologically or cytologically confirmed ASPS that is not curable by su
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: Objective response rate (ORR) [ Time Frame: 21 days (cycle 1) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response [ Time Frame: until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination ]
- Progression-free survival [ Time Frame: until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination ]
- Compare the RECIST v 1.1 vs the immune-related response criteria (irRC) in patients with ASPS on atezolizumab [ Time Frame: until disease progression, death, loss to follow-up, initiation of another anti-cancer treatment, withdrawal of consent, or study termination ]
- correlate response with expression of potential immune biomarkers in paired biopsies [ Time Frame: throughout study ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: May 3, 2017
Date Started: March 21, 2017
Date Completion: October 19, 2018
Last Updated: May 3, 2017
Last Verified: May 2, 2017
