Talimogene Laherparepvec + Radiation Therapy for Soft Tissue Sarcoma

Recruiting at 17 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects of talimogene laherparepvec and radiation therapy and to see how well they work in treating patients with newly diagnosed soft tissue sarcoma that can be removed by surgery (resectable). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays, photons. electrons, or protons to kill tumor cells and shrink tumors. Giving talimogene laherparepvec and radiation therapy may work better in treating patients with soft tissue sarcoma.

Research Team

Steven I. Robinson

Principal Investigator

Mayo Clinic Cancer Center LAO

Eligibility Criteria

Adults with newly diagnosed, potentially removable soft tissue sarcoma of the extremity or trunk (like liposarcoma or leiomyosarcoma) that's larger than 5 cm and requires radiation before surgery. Participants need normal organ function, no prior cancer treatments causing unresolved side effects, no metastatic disease, not pregnant/breastfeeding, and must agree to use contraception.

Inclusion Criteria

I have a newly diagnosed, operable soft tissue sarcoma in my limbs or trunk.

I am willing to give a tissue sample during surgery for the study.

Platelets >= 100,000/uL

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Exclusion Criteria

I have a viral infection.

My cancer has spread to other parts of my body.

Patients who are pregnant, breastfeeding or plan to become pregnant

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Treatment Details

Interventions

Radiation Therapy
Talimogene Laherparepvec

Trial OverviewThe trial is testing talimogene laherparepvec combined with radiation therapy on patients who can have their tumors surgically removed. It aims to see if this combination is more effective in treating soft tissue sarcomas compared to standard therapies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (talimogene laherparepvec, radiation therapy)Experimental Treatment5 Interventions

Patients receive talimogene laherparepvec IT or via intralesional injection at weeks 1, 4, 6 and 8. Beginning 1 week after the start of talimogene laherparepvec, patients undergo radiation therapy on Monday-Friday of weeks 2-6. Patients undergo collection of blood and a tumor biopsy on study and undergo MRI throughout the trial.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications: