HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

ConditionsGlioblastoma Multiforme Astrocytoma, Grade III

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorDavid Baskin MD

About this trial

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem involvement. Multifocal disease does not exist if enhancing areas are connected by abnormal T2 FLAIR on the MRI scan.

Radiographic evidence of recurrence/progression by iRANO criteria

≥ 3 weeks since any major surgery, completion of RT, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).

Life expectancy ≥ 12 weeks.

Disqualifiers

Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months.

Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start.

Evidence of multifocal disease, brainstem involvement

Patients on immunosuppressive drugs (other than steroids for brain edema).

Trial design

Design model

Single group

Treatments tested in this trial

ADV/HSV-tk (gene therapy)
Drug
The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy

Treatment groups

62 Participants

are divided into 1 treatment group

Group A: ADV/HSV-tk (gene therapy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Survival in months from Study drug administration (Day 0)

The overall survival in months of recurrent GBM patients drug administration up to five years

Time frame

Up to 60 months as measured in months.

Secondary outcomes

Progression Free Survival assessments will be done every 6-8 weeks for 1st year thereafter every 12-14 weeks until disease progression or death

Patients will have MRI or CT every 6-8 weeks for the first year post surgery. Thereafter patient will have MRI or CT every 12-14 weeks until completion of the protocol study specific treatment. Progression free survival will be assessed by RANO response criteria.

Time frame

Up to 60 months as measured in months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Baskin MD

Lead sponsor

The Methodist Hospital Research Institute

Sponsor institution

Center for Cell and Gene Therapy, Baylor College of Medicine

Collaborator