TVEC and Preop Radiation for Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02453191|
Recruitment Status : Recruiting
First Posted : May 25, 2015
Last Update Posted : March 22, 2018
The purpose of this research study is to determine the safety and tolerability of talimogene laherparepvec when combined with radiation therapy.
Approximately 32 people will take part in this study conducted by investigators at the University of Iowa.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: talimogene laherparepvec Radiation: Radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
talimogene laherparepvec in combination with radiotherapy
Drug: talimogene laherparepvec
Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
- Phase 1b: To determine the safety and tolerability of neoadjuvant talimogene laherparepvec in combination with preoperative EBRT [ Time Frame: 14 weeks ]Phase 1b: To determine the safety and tolerability of neoadjuvant talimogene laherparepvec in combination with preoperative EBRT as assessed by incidence of dose-limiting toxicities (DLT) in subjects with locally advanced high grade soft tissue sarcomas.
- Phase 2: To estimate the efficacy of neoadjuvant talimogene laherparepvec and radiotherapy [ Time Frame: 14 weeks ]To estimate the efficacy of neoadjuvant talimogene laherparepvec and radiotherapy as assessed by the pathological complete response rates (pCR) in subjects with histologically confirmed diagnosis of locally advanced STS that is unresectable with clear wide margins, for which preoperative radiotherapy is considered appropriate.
- Overall response rate (ORR) as measured by RECIST 1.1 or a later tool for monitoring disease progression [ Time Frame: 24 months ]
- Time to progression [ Time Frame: 24 months ]
- Overall survival rate (OS) at 5 years [ Time Frame: 5 years ]
- Patients will be monitored for adverse events to assess the safety of talimogene laherparepvec [ Time Frame: 24 months ]Information regarding the occurrence of adverse events will be collected from the time the subject signs the informed consent form and throughout their participation in the study, including a period of 30 days after the last dose of study drug (data on serious adverse events (SAEs) will be collected until resolution of the event unless otherwise noted).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453191
|Contact: Mohammed Milhem, MDemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Mohammed Milhem, MD 319-356-2324 firstname.lastname@example.org|
|Principal Investigator:||Mohammed Milhem, MD||University of Iowa|