Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to find the recommended dose level and recommended number of injections of the study agent DNX-2401 that can be given to patients with metastatic melanoma that have intracranial and/or extracranial lesions.
Description
Primary Objectives: Group A: • To determine the safety and tolerability of DNX-2401, a conditionally replication-competent adenovirus (AdV), administered to intracranial lesions in patients with metastatic melanoma as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. (Appendix 2) with evidence of stable extracranial disease, according to RECIST v1.1 criteria, while on immunotherapy. Group B: • To determine the safety and tolerability of DNX-2401, a conditionally replication-competent adenovirus (AdV), administered to extracranial les…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: (For both Groups): 1\. Patients must be 18 years old or older. 2. Patients must have a diagnosis of stage IV melanoma. 3.Patients must have an ECOG Performance status of 0 or 1 (may be obtained from medical records within 24 days of screening if not performed at screening). 4.Patients must be able to complete an MRI of the head with contrast. 5.For women of childbearing potential only, a negative urine or serum pregnancy test is required at screening. Women must agree to notify investigator immediately if they become pregnant at any time during the trial period. 6.Men a…
Interventions
- DrugDNX-2401
Given by injection
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas