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TVEC + Radiotherapy for Sarcoma

Phase 1 & 2

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.

Except certain histologic subtypes: GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas and myxoid liposarcomas (Grade 1).

Must not have

Evidence of CNS metastases.

Certain histologic subtypes: GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma bone sarcomas and low grade myxoid liposarcomas ( Grade 1).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of a new cancer treatment. 46 people will take part in the study at the University of Iowa.

Who is the study for?

Adults with a specific type of cancer called locally advanced soft tissue sarcoma (STS) that can't be completely removed by surgery. They should have tumors at least 5 cm in size suitable for radiation and direct injection or ultrasound-guided therapy. Participants must not have had certain treatments, vaccines, or other clinical trials recently and cannot have autoimmune diseases, active infections like HIV or hepatitis, or severe health issues.

What is being tested?

The trial is testing the safety and how well people tolerate combining talimogene laherparepvec (a type of oncolytic virus therapy) with radiation therapy in treating STS. About 46 participants will receive this combination treatment to see if it's an effective pre-surgical option.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, pain in affected areas due to inflammation caused by the virus attacking cancer cells combined with effects from radiation like skin irritation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

My cancer is not GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas, or Grade 1 myxoid liposarcoma.

Select...

My tumor has not been previously treated with radiation.

Select...

My cancer is at a stage where surgery alone can't remove it all.

Select...

My soft tissue sarcoma cannot be surgically removed and needs preoperative radiotherapy.

Select...

My tumor is at least 5 cm big and can be treated with radiation.

Select...

I can carry out all my self-care but not work activities.

Select...

My cancer has spread and needs radiation or surgery.

Select...

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

Select...

I have not received Talimogene laherparepvec or any cancer vaccines.

Exclusion Criteria

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

Select...

My cancer has spread to my brain.

Select...

My cancer is one of the specified types: GIST, Desmoid, Ewing sarcoma, Kaposi sarcoma, bone sarcomas, or Grade 1 low grade myxoid liposarcomas.

Select...

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

Select...

I do not have HIV.

Select...

I have a sarcoma in my abdomen or internal organs.

Select...

I have or had severe autoimmune or inflammatory bowel disease.

Select...

I currently have active herpes skin sores.

Select...

I have an active hepatitis C infection confirmed by tests.

Select...

I am on or need medication that weakens my immune system.

Select...

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

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

Select...

I had hepatitis B in the past, but now only have hidden signs of it.

Select...

I need regular medication for herpes, not just cream.

Select...

I do not have any serious illnesses that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose Limiting Toxicities (DLTs)

Pathologic Tumor Necrosis Rate

Secondary study objectives

2 Year Overall Survival

2 Year Progression-Free Survival

Overall Response Rate

Side effects data

From 2014 Phase 3 trial • 31 Patients • NCT01368276

18%

Pyrexia

18%

Chills

14%

Diarrhoea

14%

Back pain

11%

Dizziness

11%

Vomiting

11%

Oedema peripheral

11%

Upper respiratory tract infection

11%

Vitiligo

11%

Abdominal pain

11%

Fatigue

11%

Skin irritation

Abdominal discomfort

Injection site pain

Myalgia

Nausea

Ear pain

Tumour pain

Oropharyngeal pain

Headache

Pruritus

Pneumonia

Cough

Disease progression

Vasculitis

Lipoma

Hypovolaemic shock

Clavicle fracture

Influenza like illness

Lung neoplasm malignant

Cardiac arrest

Dyspnoea

Respiratory failure

Renal failure

Haemangioma of liver

Restrictive cardiomyopathy

Metastatic malignant melanoma

Pleural effusion

Ecchymosis

Hyperhidrosis

100%

80%

60%

40%

20%

Study treatment Arm

Talimogene Laherparepvec

GM-CSF

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Talimogene Laherparepvec in combination with radiotherapy-Phase I CohortExperimental Treatment2 Interventions

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

Group II: Talimogene Laherparepvec in combination with radiotherapy-Phase II CohortActive Control2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

Talimogene Laherparepvec

2008