Study on Talimogene Laherparepvec and Radiation Therapy for Treating Soft Tissue Sarcoma Before Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02923778
This clinical trial is exploring the use of talimogene laherparepvec, a biological therapy, combined with radiation therapy to treat patients with newly diagnosed soft tissue sarcoma that can be surgically removed. The study aims to determine the safety and effectiveness of this combination in shrinking tumors before surgery.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the side effects and effectiveness of combining talimogene laherparepvec, a therapy made from living organisms, with radiation therapy to treat newly diagnosed soft tissue sarcoma that can be removed by surgery. Talimogene laherparepvec may help stimulate the immune system to stop cancer cells from growing, while radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. This combination may work better in treating soft tissue sarcoma.
Description
The main goal of this study is to see how well the combination of talimogene laherparepvec (T-VEC) and radiation therapy works in causing tumor cells to die in patients with localized soft tissue sarcoma. Researchers will also look at the safety of this treatment and any complications that may occur after surgery.
Secondary goals include assessing the side effects of the treatment, how well the tumors respond before surgery, and the extent of surgical removal needed. The study will also track the time to surgery, progression of the disease, recurrence, and survival rates.
Participants will receive talimogene laherparepvec injections directly into the tumor at specific intervals, followed by radiation therapy over several weeks. Blood samples and tumor biopsies will be collected, and MRI scans will be performed to monitor the treatment's effects.
After completing the treatment, participants will have follow-up visits every few months for up to five years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a newly diagnosed soft tissue sarcoma in the arms, legs, or trunk that can be surgically removed.
- The sarcoma must be one of the following types: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma, or undifferentiated pleomorphic sarcoma.
- The tumor must be larger than 5 cm and require radiation therapy before surgery.
- Must have good overall health with a performance score of 70 or higher.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must agree to use effective contraception during the study and for four months after treatment.
- Must be willing to provide blood and tissue samples for research purposes.
- Must understand and agree to sign a written informed consent document.
Exclusion Criteria
- Have a sarcoma located in areas other than the arms, legs, or trunk.
- Have had previous treatment with certain immune therapies or radiation to the tumor site.
- Have a history of serious wounds or fractures that have not healed.
- Have active bleeding or require blood-thinning medications.
- Have metastatic disease or tumors that have spread to other parts of the body.
- Have a history of autoimmune diseases or significant immune system suppression.
- Have active viral infections, such as hepatitis B, hepatitis C, or HIV.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have any other serious medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Siteman Cancer Center at West County Hospital | 63141 | Creve Coeur | Missouri |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Siteman Cancer Center-South County | 63129 | St Louis | Missouri |
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