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Virus Therapy

C134 for Brain Tumors

Phase 1

Waitlist Available

Research Sponsored by James Markert, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed recurrent/progressive glioblastoma multiforme, Grade 3 or Grade 4 astrocytoma, or gliosarcoma

Age ≥18 years

Must not have

History of any lymphoproliferative disorder

Enhancing tumor diameter larger than 5.5 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment - 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and tolerance of a new drug called C134 when injected directly into the brain where the tumor is. It is a Phase IB 2 dosing study, with all patients

Who is the study for?

This trial is for a small group of 4-12 patients with recurrent malignant glioma, which includes specific brain tumors like glioblastoma and astrocytoma. Participants must have a tumor that can be reached to administer the treatment directly.

What is being tested?

The study is testing the safety and tolerability of an experimental drug called C134 when injected twice into the brain tissue where the tumor is located. There's no placebo; all participants receive the actual drug in their tumor infiltrated tissue.

What are the potential side effects?

Since this summary does not provide specific side effects, it's important to note that potential side effects could range from local reactions at injection sites to more systemic effects due to immune response or direct impact on brain function.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is a type of aggressive brain tumor.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

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My organs and bone marrow are functioning normally.

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I am not pregnant.

Exclusion Criteria

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

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I have had a condition where my lymphocytes grow abnormally.

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My tumor is larger than 5.5 cm.

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My cancer affects areas that need targeted treatment.

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I currently have an active cold sore.

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I received Bevacizumab therapy less than 4 weeks ago.

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I have had severe allergic reactions to C134 or similar drugs.

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I have a history of cancer.

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I am currently taking medication for herpes.

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I have never had encephalitis, multiple sclerosis, or active infections in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment - 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment - 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment - 12 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety of a two dose intracerebral injection of C134 virus

Secondary study objectives

Composition of the white blood cells

Measure interferon levels

Measurement of HSV Titer

+2 more

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

Group I: Initial TreatmentExperimental Treatment1 Intervention

Patients will undergo a contrasted MRI scan to determine the site for stereotactic biopsy. For dose #1, patients will be treated under monitored local anesthesia, or at the surgeon's discretion, under general anesthesia. Patients will then undergo stereotactic biopsy of their tumor. While evidence of radiation damage or necrosis may be present on the frozen section, inoculation with C134 will only proceed if viable, recurrent glioma is also present on the frozen section. The dose level of C134 will be 1 x 105 plaque forming units (pfu). Virus will be inoculated via catheters placed stereotactically in enhancing regions of tumor or immediately adjacent in non-enhancing tumor infiltrated regions at up to 5 different loci (each injection over 2 minutes). Catheters will be removed directly after administration for treatment 1.

Group II: 2nd TreatmentExperimental Treatment1 Intervention

Before dose #2 administration, patients will undergo preoperative assessment of their disease status. If they are deemed to have had a complete response (CR), no treatment will be undertaken until there is evidence of a possible recurrence. If this does not occur until after week 16, the patient's situation will be discussed with the DSMB and a decision made about possible second treatment. If the patient has had a partial response or stable disease, and their tumor remains less than 5.5 cm in size, they wil lbe treated with stereotactic biopsy using the same technique described for dose #1 If the patient has suffered progression or peudoprogression, or if in the estimation of the surgeon it is not safe to perform inoculation alone, they will undergo craniotomy for resection of the tumor.

0 / 14Eligibility criteria met