Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Talimogene laherparepvec

Antineoplastic Agents, Immunological

Talimogene Laherparepvec Dose Levels:

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Dose -1 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed every 2 weeks

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

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.

Radiotherapy

Mohammed Milhem, MD

The purpose of this research study is to determine the safety and tolerability of talimogene laherparepvec when combined with radiation therapy.

Approximately 46 people will take part in this study conducted by investigators at the University of Iowa.

This is a single-arm open-label phase Ib and phase II clinical study assessing the safety and relative efficacy of concurrent talimogene laherparepvec in combination with radiotherapy in patients with soft tissue sarcomas. 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.

TVEC and Preop Radiation for Sarcoma (8 ml Dose)

Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas

A DLT is defined as any of the following talimogene laherparepvec-related toxicity or related to the combination of talimogene laherparepvec and radiation therapy during treatment and up to 4 weeks after the last talimogene laherparepvec injection: Grade 3 or greater immune-mediated adverse events, Grade 3 or greater allergic reactions, any grade plasmacytoma, any other unexpected grade 3 or greater hematologic or non-hematologic toxicity, with the exceptions of: any grade of alopecia, expected radiation related skin toxicity of any grade, Grade 3 arthralgia or myalgia, brief (\< 1 week) grade 3 fatigue, Grade 3 fever, Grade 3 diarrhea or vomiting responding to supportive case.

Pathologic tumor necrosis rate is defined as the percentage of subjects with pathologic tumor necrosis ≥ 90%.

Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per RECIST v1.1.

Progression-free survival is defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients are censored at the date of last radiographic assessment for progression.

Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.

Amgen

Mohammed Milhem

Clinical Professor

Talimogene Laherparepvec in combination with radiotherapy

Talimogene Laherparepvec Dose Levels:

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Talimogene Laherparepvec: Talimogene Laherparepvec

Radiotherapy: 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.

Talimogene Laherparepvec in Combination With Radiotherapy-Phase I

Talimogene Laherparepvec Dose Level:

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Radiotherapy: 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.

Talimogene Laherparepvec in Combination With Radiotherapy-Phase II

Talimogene Laherparepvec in combination with radiotherapy Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Talimogene Laherparepvec: Talimogene Laherparepvec

Radiotherapy: 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.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Enrollment halted prematurely due to funding. Participants are being followed for secondary outcome measures.

Varun Monga, MD

Talimogene Laherparepvec in combination with radiotherapy

Talimogene Laherparepvec Dose Levels:

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Radiotherapy: 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.

Talimogene Laherparepvec in Combination With Radiotherapy-Phase I Cohort

6 participants enrolled in the Phase 1 portion (Talimogene Laherparepvec Dose 0) and completed treatment, radiation, and surgical resection.

Number of Participants With Dose Limiting Toxicities (DLTs)

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Talimogene Laherparepvec: Talimogene Laherparepvec

Radiotherapy: 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.

Talimogene Laherparepvec in Combination With Radiotherapy

8 participants received Dose Level 0 and were included in the analysis for pathologic tumor necrosis

Pathologic Tumor Necrosis Rate

Overall Response Rate

2 Year Progression-Free Survival

2 Year Overall Survival

Talimogene Laherparepvec Dose Levels:

Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly

Radiotherapy: 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.

Spots Global Cancer Trial Database for TVEC and Preop Radiation for Sarcoma (8 ml Dose)

Trial Identification

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Interventions

Study Description

Keywords

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