The study will be a single-institution, open-label, single-arm phase II study. Patients will be treated with twice daily dosing of axitinib alone for the first 7 days, followed by concurrent axitinib administered twice daily at 5 mg orally (PO), plus intravenous administration of pembrolizumab every 21 days. Patients will be assessed every three weeks for toxicity. After the first five patients are enrolled, the investigators will assess safety of the combination.
Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Eligibility: 16 Years and older.
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The NCI will accept and pay travel also for ASPS patients who are not US residents. Non-US residents need to arrive to any US port and then their flight to the NCI, their treatment and minimal stay will be paid by the NCI!
National Institutes of Health Clinical Center (CC)
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01391962 |
Contacts and Locations
Contacts
| Contact: NCI Referral Office | 1-888-NCI-1937 |
Locations
| United States, California | |
| Santa Monica Oncology Center | Recruiting |
| Santa Monica, California, United States, 90403 | |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030-4096 | |
Sponsors and Collaborators
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Cediranib (AZD2171): Phase II Study in Patients With Alveolar Soft Part Sarcoma
Sponsored by: National Cancer Institute (NCI)
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.
Objective:
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
Contact:
NCI Referral Office 1-888-NCI-1937 ncicssc@mail.nih.gov
Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
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ARQ 197: Clinical Trial for Patients with Alveolar Soft Part Sarcoma
The purpose of this phase 2 study is to determine the overall response rate in patients with unresectable locally advanced or metastatic alveolar soft parts sarcoma, clear cell sarcoma or translocation associated renal cell carcinoma. The study will enroll adolescent (age 13 or older) and adult patients with a histologically or cytologically confirmed MiT malignant disease. Eligible patients will receive ARQ 197 twice daily. Treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.
ARQ 197 is an oral drug in the family of targeted therapies. It is c-Met inhibitor, an investigational drug.
For more information click the following links:
1. The National Institutes of Health
2. ArQule, the biotech company that develops ARQ197
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The GVAX Cancer Vaccine Clinical Trial for ASPS patients is ongoing, but not recruiting participants anymore. This clinical trial was opened at the Dana-Farber Cancer Institute, Boston (click the following links for more information)
1. Announcement of the ASPS Clinical Trial on the US National Institute of Health
3. The GVAX Cancer Vaccine Trial at the Dana Farber Cancer Institute – Details