Talimogene Laherparepvec + Radiation Therapy for Soft Tissue Sarcoma
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on medications for autoimmune diseases or are receiving systemic immunosuppressive therapy, you may not be eligible to participate.
What data supports the effectiveness of this treatment for soft tissue sarcoma?
Research shows that advanced radiotherapy techniques like image-guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT) have significantly improved the treatment of soft tissue sarcoma by enhancing local control of the tumor. Additionally, stereotactic body radiation therapy (SBRT) has been effective in controlling tumors in patients with limited metastases, achieving high control rates at treated sites.12345
Is the combination of Talimogene Laherparepvec and radiation therapy generally safe for humans?
Research shows that combining stereotactic radiotherapy (a precise form of radiation therapy) with other treatments like immunotherapy can increase both effectiveness and side effects. Some studies have reported unexpected side effects, especially in the gastrointestinal system, when combining advanced radiation techniques with certain drugs. It's important to be aware of these potential risks when considering such treatments.678910
What makes the treatment with Talimogene Laherparepvec and Radiation Therapy unique for soft tissue sarcoma?
This treatment is unique because it combines Talimogene Laherparepvec, a virus-based therapy that helps the immune system attack cancer cells, with various forms of radiation therapy to enhance the overall effectiveness against soft tissue sarcoma. This combination aims to improve tumor response by leveraging both direct cancer cell destruction and immune system activation.1112131415
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talimogene laherparepvec intratumorally or via intralesional injection at weeks 1, 4, 6, and 8, and undergo radiation therapy Monday-Friday of weeks 2-6
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Radiation Therapy
- Talimogene Laherparepvec
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor