MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03896568
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • IDH1 wt Allele
  • Recurrent Anaplastic Astrocytoma
  • Recurrent Glioblastoma
  • Recurrent Gliosarcoma
  • Recurrent Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oncolytic Adenovirus Ad5-DNX-2401 — BIOLOGICAL
    Given IA
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.

Key Dates

Start date
Feb 12, 2019
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I (oncolytic adenovirus Ad5-DNX-2401)
    Patients receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes on day 0.
  • Experimental: Part II (oncolytic adenovirus Ad5-DNX-2401, surgery)
    Patients receive oncolytic adenovirus Ad5-DNX-2401 as in part I. After 2 weeks, patients undergo surgery, then receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes.

Primary Outcome Measure

Maximum-tolerated dose (MTD) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Frederick F. Lang
713-792-2400
Frederick F. Lang (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
M D Anderson Cancer Center· Houston, TX

Related Studies