Safety Study of Modified Vaccinia Virus to Cancer
A Phase I Dose-escalation Trial of vvDD-CDSR (Double-deleted Vaccinia Virus Plus CD/ SMR) Administered by Intratumoral Injection or Intravenous Injection
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to determine the safety and maximum tolerated dose from injecting this vaccinia virus into tumors or infusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedDecember 28, 2015
December 1, 2015
4.7 years
December 13, 2007
December 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the maximally tolerated dose (MTD) and/or maximum-feasible dose (MFD) and Safety of vvDD-CDSR administered by intratumoral (I.T.) injection and intravenous (I.V.) infusion.
28 days
Secondary Outcomes (3)
Replication/pharmacokinetics of vvDD-CDSR
28 days
Immune response to vvDD-CDSR and to the tumor following administration
28 days
Antitumoral efficacy of vvDD-CDSR
28 days
Study Arms (3)
A
EXPERIMENTALSubjects who have been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection
B
EXPERIMENTALSubjects will include those who have not been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection.
C
EXPERIMENTALSubjects will be those who have been vaccinated with vaccinia virus (small pox)and will be receiving the vvCD-CDSR via intravenous infusion
Interventions
Eligible subjects will receive 1 treatment of vvDD-CDSR. A dose can be divided between 1-3 lesions. The sum total of the maximal diameters of the lesion(s) to be injected must be \< 10cm. Cohort 1: 3 x 10e7 p.f.u. Cohort 2: 1 x 10e8 p.f.u. Cohort 3: 3 x 10e8 p.f.u. Cohort 4: 1 x 10e9 p.f.u. Cohort 5: 3 x 10e9 p.f.u.
Eligibility Criteria
You may qualify if:
- Greater than 18 years of age
- Histologically-confirmed cancer that has progressed despite standard therapy. They must have one of the following tumor-types: melanoma, breast cancer, or head and neck squamous cell cancer, liver, colorectal or pancreatic
- Cancer is not surgically curable
- Karnofsky Performance Status (KPS) of \> 70 (See Appendix B)
- Anticipated survival of at least 16 weeks
- If sexually-active, willingness to use condoms for 3 months following study treatment with vvDD-CDSR
- The ability to understand and willingness to sign a written informed consent
- Able to comply with study procedures and follow-up examinations
- Adequate bone marrow function: WBC \> 3,500 and \<50,000 cells/mm3, ANC \> 1,500 cells/mm3, hemoglobin \> 10 g/dL, and platelet count \> 150,000 cells/mm3
- Adequate renal function: serum creatinine level ≤ 1.2 x ULN
You may not qualify if:
- Pregnant or nursing an infant
- Active viral infection (including HIV, Hepatitis B and C)
- Systemic corticosteroid or other immunosuppressive medication use within 4 weeks of the treatment
- Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment
- Significant immunodeficiency (e.g. due to underlying illness and/ or medication) in subject or household contacts
- History of eczema requiring systemic therapy
- Unstable cardiac disease which includes but is not limited to: Any of the following within 6 months prior to study entry: MI, unstable angina, congestive heart failure, myocarditis, arrhythmias diagnosed and requiring medication, or any clinically-significant change in cardiac status
- Target tumor(s) adherent to a major vascular structure (e.g. carotid artery)
- Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy in 4 weeks prior to study screening
- Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
- Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
- Subjects with household contacts who are pregnant or nursing an infant, children \< 5 years old, have history of eczema that at some stage has required systemic therapy, or have a significant immunodeficiency due to underlying illness (e.g. HIV) and/or medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the last dose of study medication
- Inability or unwillingness to give informed consent.
- CD4 T cell count \< 350 per µL blood
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Bartlettlead
Study Sites (1)
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Herbert J. Zeh, MD, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief, Division of Surgical Oncology
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
May 1, 2008
Primary Completion
January 1, 2013
Study Completion
July 1, 2014
Last Updated
December 28, 2015
Record last verified: 2015-12