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Virus Therapy

Talimogene Laherparepvec for Soft Tissue Sarcoma

Phase < 1

Waitlist Available

Led By John Rieth, MD

Research Sponsored by John Rieth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Patient must have injectable disease (direct injection or ultrasound guided)

Must not have

Active herpetic skin lesions

History or evidence of sarcoma associated with immunodeficiency states (e.g.: Hereditary immune deficiency, HIV, organ transplant or leukemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to treat a specific type of advanced soft tissue cancer using a combination of a virus-based therapy and radiation before surgery.

Who is the study for?

Adults (18+) with certain types of large, locally advanced soft tissue sarcomas that can't be surgically removed with clear margins and are suitable for radiation. Participants must have finished any previous cancer treatments at least a year prior to joining the trial, not have active infections like herpes or hepatitis, no autoimmune diseases, not be pregnant or breastfeeding, and agree to use effective contraception.

What is being tested?

The study is testing the combination of an experimental drug called Talimogene Laherparepvec injected directly into the tumor along with standard preoperative external beam radiation therapy. The goal is to see if this combo is more effective in treating soft tissue sarcoma than current methods.

What are the potential side effects?

Talimogene Laherparepvec may cause flu-like symptoms, fatigue, nausea, injection site pain or swelling. Radiation therapy might lead to skin changes or irritation where it's applied and general tiredness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My disease can be treated with injections guided by sight or ultrasound.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My sarcoma cannot be fully removed by surgery and needs preoperative radiotherapy.

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My tumor is at least 5 cm large and can be measured by scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active herpes skin sores.

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I have a sarcoma linked to an immune deficiency like HIV or after an organ transplant.

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I am currently on or need immunosuppressive therapy.

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I have a history of severe autoimmune disease like rheumatoid arthritis or lupus.

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My cancer has spread to my brain.

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I have tested positive for hepatitis B.

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My sarcoma is not classified as undifferentiated pleomorphic, myxofibrosarcoma, or MPNST.

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I do not have HIV.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I have a sarcoma in my abdomen or internal organs.

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I have had my spleen removed or it has been treated with radiation.

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I have active hepatitis C, confirmed by positive tests.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Expansion PilotExperimental Treatment3 Interventions

Patients will be treated with neoadjuvant radiation and weekly intratumoral injections of talimogene laherparepvec. Weekly injections of talimogene laherparepvec will be continued until surgery. Surgery will be performed 4-6 weeks from the end of radiation therapy to allow for resolution of acute toxicities per current standard of care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talimogene Laherparepvec

2008

Completed Phase 3

~630

Surgery

2000

Completed Phase 3

~2490