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

August 12, 2013 updated by: Martha Mims, Baylor College of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pre-treatment visit - subject will undergo a physical examination with vital signs, a blood sample will be taken and a PET (Positron emission tomography)-CT (Computer tomography) scan will be performed.

Thereafter, there will be 4 visits with injections performed on trial days 1, 4, 8 and 15.

TREATMENT:

The injections are given directly into the tumors with help from using an ultrasound. The total dose of oncolytic virus the subject will receive will be divided into 1-10 injections which will be injected into individual tumors in the body. The maximum number of tumors that can be injected for one treatment will be 10 tumors.

STUDY VISIT 1:

On the day 1 visit, blood samples will be taken as well as two biopsies from one of the tumors. In addition pleural fluids (fluids from the chest) or ascites (fluids from abdominal walls) may be collected if possible. Then the subject will receive the first set of injections with CGTG-102. Before the injections, the subject may be given a dose of Tylenol.

STUDY VISIT 2:

On the day 4 visit, in addition to blood samples being taken the subject will receive a second round of intratumoral injections into the same tumors selected for injections on day 1. Urine will also be collected right before the subject goes home.

STUDY VISIT 3:

The day 8 visit is identical to the day 4 visit. The same blood samples and urine sample are taken.

STUDY VISIT 4:

On the day 15 visit blood samples and a urine sample will be taken as well as a biopsy from one of the tumors.

Subjects will have to stay overnight at the hospital after each treatment.

FOLLOW UP:

A follow-up visit will be scheduled on days 29 where only blood samples and a urine sample will be taken.

The end of trial visit is scheduled around day 43 where in addition to lab samples a PET-CT scan will be performed.

Following day 43 the subject will be contacted by study staff at 6 week intervals for 3 months, then at 3 month intervals for up to one year and yearly thereafter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  1. Age 18 - 70 years
  2. Histologically-confirmed, advanced/metastatic solid tumor that is relapsed and/or refractory to standard therapy (progressive disease despite therapy).
  3. Cancer is not surgically resectable for cure.
  4. At least one measurable tumor mass by PETCT (i.e. PET-positive lesion that can reliable be assessed for SUV (standard update value) peak/SUV max, typically featuring longest diameter greater than or equal to 1 cm) and that can be injected by direct visualization/palpitation or by imaging-guidance (ultrasound)
  5. Tumor suitable for biopsy. Biopsy is to be performed twice during the study (day 1 and day 15). The aim is to biopsy the same tumor at these visits.
  6. Expected survival for approximately 12 weeks or longer
  7. Performance Status WHO (World Health Organization) 0-2
  8. Total bilirubin less than or equal to ULN (Upper Limit of Normal)
  9. AST (Aspartate transaminase), ALT (Alanine aminotransferase) less than or equal to 3.0 × ULN
  10. Serum creatinine less than or equal to 1.5 x ULN
  11. INR (International Normalized Ratio) less than or equal to 1.5 x ULN

  12. Hematologic parameters: Patients can be transfused to meet these entry criteria:

    1. Hemoglobin greater than or equal to 10 g/dL
    2. Leucocytes greater than or equal to 2300/mL
    3. platelet count greater than or equal to 75,000 plts/mm
  13. Willing to participate as demonstrated by signed informed consent form.

EXCLUSION CRITERIA:

  1. Known brain metastases or glioma. Central Nervous System malignancy, including carcinomatosis meningitis.
  2. Tumor in the immediate pericardial vicinity

  3. Use of high dose systemic corticosteroids or other immune suppressive medication within 3 weeks of first treatment.

    Note: patients taking low-dose corticosteroids for the treatment of nausea and/or taking maintenance corticosteroids for adrenal insufficiency are permitted to enroll.

  4. Known infection with HIV (Human immunodeficiency virus) as this would affect the immune response of treatment or known underlying genetic immunodeficiency disease
  5. Treatment of the injected tumor(s) with radiotherapy, chemotherapy, surgery, or an investigational drug within 4 weeks prior to first treatment.
  6. Use of anti-viral medication. [Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.]
  7. Recent thromboembolic event
  8. Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment (e.g. pulmonary, neurological, cardiovascular, metabolic such as type 2 diabetes, clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions)
  9. Severe or unstable cardiac disease.
  10. Current, active, progressing CNS (Central nervous system) malignancy, including carcinomatosis meningitis (definitively surgically resected or irradiated metastases allowed)
  11. Pulse oximetry O2 (oxygen) criterion <90% at rest on room air
  12. Vaccination with a live virus (i.e. measles, mumps, rubella, etc) < 30 days prior to first treatment
  13. History of hepatic dysfunction, cirrhosis, hepatitis or malaria
  14. Evidence of coagulation disorder
  15. Women who are pregnant or nursing an infant
  16. Previous organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CGTG-102
CGTG-102 is an oncolytic adenovirus
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of CGTC-102 in patients with solid tumors
Time Frame: 28 days
To assess the safety of the maximum tolerated dose and/or maximum feasible dose of CGTG-102 administered by intratumoral injection in a patient population with unresectable, refractory solid tumors
28 days
Efficacy of CGTC-102 in patients with solid tumors
Time Frame: 28 days
To determine the maximum tolerated dose and/or maximum feasible dose of CGTG-102 administered by intratumoral injection in a patient population with unresectable, refractory solid tumors
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development of tumor following the injection
Time Frame: 43 days
To measure the development of adenovirus and tumor specific humoral responses following virus injection
43 days
Development of cellular immune response following the injection
Time Frame: 43 days
To measure the development of cellular immune responses following virus injection
43 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harris County Hospital District
The Methodist Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martha M Pritchett, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-28686-GOAT
  • GOAT (CAGT/BCM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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