Atezolizumab for Sarcoma

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byA P Chen

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well atezolizumab works in treating patients with chondrosarcoma or clear cell sarcoma that is newly diagnosed, cannot be removed by surgery (unresectable), or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Research Team

A P Chen

Principal Investigator

National Cancer Institute LAO

Eligibility Criteria

This trial is for children and teens aged 2-17 with clear cell sarcoma or advanced chondrosarcoma that's either new, can't be surgically removed, or has spread. They should have a life expectancy over 3 months, certain blood counts within range, measurable disease, and no major health issues that could affect the trial. They must not have had recent vaccines or antibiotics and cannot be pregnant.

Inclusion Criteria

My kidney function, measured by creatinine clearance, is adequate.

I have a specific type of cancer that is spreading and causing more symptoms.

Your hemoglobin (a protein in your blood) levels are at least 8 grams per deciliter (a unit of measurement for blood).

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Exclusion Criteria

You cannot have participated in any other experimental treatment within the last 4 weeks (or within five half lives of the investigational product, whichever is shorter) before starting this study.

I do not have any unmanaged ongoing illnesses.

I have active tuberculosis.

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Treatment Details

Interventions

Atezolizumab (Checkpoint Inhibitor)

Trial OverviewThe study tests Atezolizumab's effectiveness against specific sarcomas in young patients. It involves collecting biospecimens and using CT scans to monitor the cancer's response to this immunotherapy drug designed to boost the body’s immune system in fighting cancer cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (atezolizumab)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over 30-60 minutes on ay 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and undergo biopsy and collection of blood samples on study.