Therapeutic Conventional Surgery for Anaplastic Astrocytoma

M D Anderson Cancer Center, Houston, TX
Anaplastic Astrocytoma+4 More ConditionsTherapeutic Conventional Surgery - Procedure
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new virus treatment for brain cancer. The virus is made to only attack cancer cells, and not healthy cells.

Eligible Conditions
  • Recurrent Anaplastic Astrocytoma
  • Gliosarcoma
  • Isocitrate Dehydrogenase 1 Wildtype Allele
  • Glioblastoma (GBM)
  • Brain Tumor

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 1 year

Up to 1 year
Immunogenicity based on adenoviral (AdV) antibodies
Incidence of adverse events (AEs)
Time to progression
Tumor response
Virus replication in tumor
Virus shedding
Up to 28 days
Maximum-tolerated dose (MTD)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Part II (oncolytic adenovirus Ad5-DNX-2401, surgery)
1 of 2
Part I (oncolytic adenovirus Ad5-DNX-2401)
1 of 2

Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Therapeutic Conventional Surgery · No Placebo Group · Phase 1

Part II (oncolytic adenovirus Ad5-DNX-2401, surgery)Experimental Group · 2 Interventions: Therapeutic Conventional Surgery, Oncolytic Adenovirus Ad5-DNX-2401 · Intervention Types: Procedure, Biological
Part I (oncolytic adenovirus Ad5-DNX-2401)
Experimental Group · 1 Intervention: Oncolytic Adenovirus Ad5-DNX-2401 · Intervention Types: Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,489 Total Patients Enrolled
DNAtrix, Inc.Industry Sponsor
7 Previous Clinical Trials
212 Total Patients Enrolled
Frederick F LangPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Has the FDA given sign-off to Therapeutic Conventional Surgery?

"The safety of Therapeutic Conventional Surgery is estimated to be a 1 given the limited evidence currently available. This is supported by its Phase 1 trial status, which suggests few studies have been conducted on efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Are there any spots open to join this research endeavor?

"Affirmative. According to the information found on, this medical study is actively recruiting participants since its posting date on February 12th 2019 and latest update on August 11th 2022. This clinical trial seeks 36 patients from one location specifically." - Anonymous Online Contributor

Unverified Answer

How many individuals can enrol in this clinical experiment?

"Affirmative. As reported on, this medical trial is presently recruiting participants and was first posted on February 12th 2019 with the most recent edit being made on August 11th 2022. The research team needs to enroll 36 patients from one centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.