MedTrace Logo

GOAT; Phase I Open Label Study of CGTG-102, a GM-CSF Encoding Oncolytic Adenovirus, for Advanced Cancers

NCT01437280 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-08-14

No results posted yet for this study

Summary

Oncolytic viruses are viruses that can be found in nature, but they have been modified so that they can no longer multiply in normal cells. These viruses "infect" cancer cells and kill them. Once the cancer cell dies thousands of the viruses are released and can potentially infect other cancer cells in the area. The effects of oncolytic viruses on the tumor are felt to be the result of a combination of the oncolytic viruses directly killing the tumor cells as well as the patient's immune system killing cancer cells that are infected with the oncolytic virus.

Modern oncolytic viruses have been used for treatment of thousands of patients. The safety of such treatments has been good and there have been no deaths caused by treatment with oncolytic viruses. Many patients have benefited from the treatment in the sense that their tumors have stopped growing, become smaller or even completely disappeared. Some benefits are temporary, but about one third of patients seem to gain longer lasting benefit likely to impact survival. The effect of oncolytic viruses on improving survival has not been demonstrated yet.

Oncolytic viruses can be created from many different types of viruses. In this study the investigators are using an oncolytic virus created from an adenovirus. Adenoviruses are the types of viruses that cause the common cold and the flu. Because replication in normal cells does not take place, these oncolytic viruses should not cause any diseases in normal cells. Further, to date there has been no incidence of passing the virus on to other humans from patients who were treated with oncolytic viruses.

The purpose of this study is to see the highest dose of CGTG-102 (the oncolytic virus being used in this study) that can safely be given to subjects. The investigators will also evaluate whether or not the CGTG-102 is helpful in reducing the size of the cancer and improving patient survival.

Conditions

Interventions

BIOLOGICAL

CGTG-102

VP=virus particle Dose Level 1: 3x10\^10 VP/injection Dose Level 2: 1x10\^11 VP/injection Dose Level 3: 3x10\^11 VP/injection Patients will receive 4 administrations of CGTG-102 (on days 1, 4, 8, 15). Escalation to the next dose level will occur when the safety of all 4 administrations has been evaluated at day 43 on all patients in the preceding dose level. The total dose will be injected into up to 10 tumors injectable by either direct visualization/palpitation and/or ultrasound. Typically, the largest safely injectable tumors are chosen. Injections will be performed by a radiologist or other trained physician. Injections will be planned based on the baseline PET-CT: only PET-positive tumors or tumor regions should be injected. Injection needles designed for percutaneous insertion into tissues will be used.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Harris County Hospital District

    collaborator OTHER_GOV

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Martha M Pritchett, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437280 on ClinicalTrials.gov