Study on Atezolizumab Alone or with Bevacizumab for Advanced Alveolar Soft Part Sarcoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03141684
This clinical trial is exploring how well the drug atezolizumab, alone or combined with bevacizumab, works in treating advanced alveolar soft part sarcoma, a type of cancer that cannot be removed by surgery and has spread to other parts of the body.
Patient Parameters
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Program Overview
The study aims to find out if atezolizumab, a drug that helps the immune system attack cancer cells, can shrink tumors in patients with advanced alveolar soft part sarcoma. It also examines if adding bevacizumab, which controls blood vessel growth, can improve treatment outcomes. Patients will receive either atezolizumab alone or in combination with bevacizumab, depending on their previous treatment responses.
Description
This study is divided into two groups:
- Group 1: Patients receive atezolizumab through an IV drip every 21 days. If their cancer progresses, they may switch to Group 2.
- Group 2: Patients receive both atezolizumab and bevacizumab through an IV drip every 21 days.
The main goals are to see how well these treatments work in shrinking tumors and to monitor the safety and side effects. Researchers will also study how long the treatment effects last and how the immune system responds to the drugs.
Participants will undergo regular CT scans and provide blood and urine samples to track their progress. After completing the treatment, patients will be followed up for about a month, and those who remain stable after a two-year break from treatment will have check-ups every six months.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with alveolar soft part sarcoma that cannot be cured by surgery.
- Cancer must be measurable by scans or physical exams.
- For atezolizumab alone, patients must be 2 years or older; for the combination with bevacizumab, patients must be 18 years or older.
- Good overall health with a performance status score of 2 or less.
- Life expectancy of more than 3 months.
- Adequate blood cell counts and organ function as determined by specific tests.
- Women of childbearing potential and men must agree to use effective contraception during and after the study.
- Willing to provide biopsy samples for research (adults only).
- Able to understand and sign a consent form.
Exclusion Criteria
- Recent treatment with other cancer therapies or investigational drugs.
- History of severe allergic reactions to similar drugs.
- Active infections or other serious medical conditions.
- Pregnant or breastfeeding women.
- Patients with certain autoimmune diseases or significant liver disease.
- Recent major surgery or planning to have major surgery during the study.
- Use of certain medications that may interfere with the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Keck Medicine of USC Buena Park | 90621 | Buena Park | California |
| Keck Medicine of USC Koreatown | 90020 | Los Angeles | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| Keck Medical Center of USC Pasadena | 91105 | Pasadena | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Smilow Cancer Hospital-Derby Care Center | 06418 | Derby | Connecticut |
| Smilow Cancer Hospital Care Center-Fairfield | 06824 | Fairfield | Connecticut |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
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