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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, ECOG performance status of 0-1. No evidence of other active malignancy (except squamous or basal cell skin cancers).
Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol: serum creatinine < 1.5 mg/dL, T. bilirubin < 2.5 mg/dL, ALT, AST, GGT and Alk Phos < 2 x normal, Platelet count > 100,000/ml , ANC> 1500/ml , Hgb> 10 gm/dL, Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 60 months measured in months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is studying how well HSV-tk (gene therapy), valacyclovir, radiotherapy, and chemotherapy work in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.
Eligible Conditions
- Glioblastoma
- Anaplastic Astrocytoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months measured in months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months measured in months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival in months up to 5 years from Study drug administration (Day 0)
Secondary outcome measures
Progression free survival assessments will be done every 6-8 weeks for 1st year thereafter every 12-14 weeks until disease progression or death
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: ADV/HSV-tk (gene therapy)Experimental Treatment1 Intervention
Experimental: ADV/HSV-tk (gene therapy)
The gene therapy investigational product, HSV-tk will be injected during the surgery. Within 24 hours valacyclovir will be given for 14 days. Radiotherapy will be administered over 30 sessions (over 6 weeks) starting within 9 days of surgery. Standard of care/routine chemotherapy will be started concurrent with the radiotherapy dependent on patient status based on best clinical judgment following the Stupp protocol.
Patient can receive second treatment of HSV-tk after 6 months.
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
252 Previous Clinical Trials
76,247 Total Patients Enrolled
4 Trials studying Glioblastoma
86 Patients Enrolled for Glioblastoma
David S. Baskin, MDPrincipal InvestigatorHouston Methodist Neurological Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are okay with providing tissue samples for the study.The patient is allowed to receive a second treatment of HSV-tk after a 6 month period.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: ADV/HSV-tk (gene therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people fit the requirements for participation in this research project?
"That is accurate, the trial information on clinicaltrials.gov reveals that the study is looking for additional participants. The study was first posted on February 28th, 2018, with the most recent update being on September 3rd, 2020. The study is looking for 62 individuals at 1 location."
Answered by AI
Are there any current openings for new enrollees in this clinical trial?
"Yes, this trial is still recruiting patients. According to the information available on clinicaltrials.gov, the trial was first posted on February 28th, 2018 and was most recently updated on September 3rd, 2020."
Answered by AI
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