Status:
WITHDRAWN
GOAT; Phase I Open Label Study of CGTG-102, a GM-CSF Encoding Oncolytic Adenovirus, for Advanced Cancers
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Harris County Hospital District
Conditions:
Tumors
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 performe...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 18 - 70 years
- Histologically-confirmed, advanced/metastatic solid tumor that is relapsed and/or refractory to standard therapy (progressive disease despite therapy).
- Cancer is not surgically resectable for cure.
- 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)
- 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.
- Expected survival for approximately 12 weeks or longer
- Performance Status WHO (World Health Organization) 0-2
- Total bilirubin less than or equal to ULN (Upper Limit of Normal)
- AST (Aspartate transaminase), ALT (Alanine aminotransferase) less than or equal to 3.0 × ULN
- Serum creatinine less than or equal to 1.5 x ULN
- INR (International Normalized Ratio) less than or equal to 1.5 x ULN
- Hematologic parameters: Patients can be transfused to meet these entry criteria:
- Hemoglobin greater than or equal to 10 g/dL
- Leucocytes greater than or equal to 2300/mL
- platelet count greater than or equal to 75,000 plts/mm
- Willing to participate as demonstrated by signed informed consent form.
- EXCLUSION CRITERIA:
- Known brain metastases or glioma. Central Nervous System malignancy, including carcinomatosis meningitis.
- Tumor in the immediate pericardial vicinity
- 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.
- Known infection with HIV (Human immunodeficiency virus) as this would affect the immune response of treatment or known underlying genetic immunodeficiency disease
- Treatment of the injected tumor(s) with radiotherapy, chemotherapy, surgery, or an investigational drug within 4 weeks prior to first treatment.
- Use of anti-viral medication. \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\]
- Recent thromboembolic event
- 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)
- Severe or unstable cardiac disease.
- Current, active, progressing CNS (Central nervous system) malignancy, including carcinomatosis meningitis (definitively surgically resected or irradiated metastases allowed)
- Pulse oximetry O2 (oxygen) criterion \<90% at rest on room air
- Vaccination with a live virus (i.e. measles, mumps, rubella, etc) \< 30 days prior to first treatment
- History of hepatic dysfunction, cirrhosis, hepatitis or malaria
- Evidence of coagulation disorder
- Women who are pregnant or nursing an infant
- Previous organ transplant
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01437280
Last Update
August 14 2013
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