Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2008-05-31
2014-07-31
Brief Summary
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Detailed Description
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Once the MTD and/or MFD has been defined in the vaccinated I.T. arm described above, additional subject may be enrolled at one dose level lower than the MTD/MFD and the I.V. infusion phase may begin. Patients enrolled in the IV infusion arm will receive a single administration of vvDD-CDSR at one of three dose levels in a sequential dose-escalating design.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Subjects who have been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection
Vaccinia virus (vvDD-CDSR)
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.
B
Subjects will include those who have not been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection.
Vaccinia virus (vvDD-CDSR)
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.
C
Subjects will be those who have been vaccinated with vaccinia virus (small pox)and will be receiving the vvCD-CDSR via intravenous infusion
Vaccinia virus (vvDD-CDSR)
Eligible subjects will receive 1 infusion of vvDD-CDSR.
Cohort 1: 3 x 10e8 p.f.u; Cohort 2: 1 x 10e9 p.f.u.; Cohort 3: 3 x 10e9 p.f.u.
Interventions
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Vaccinia virus (vvDD-CDSR)
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.
Vaccinia virus (vvDD-CDSR)
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.
Vaccinia virus (vvDD-CDSR)
Eligible subjects will receive 1 infusion of vvDD-CDSR.
Cohort 1: 3 x 10e8 p.f.u; Cohort 2: 1 x 10e9 p.f.u.; Cohort 3: 3 x 10e9 p.f.u.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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David Bartlett
OTHER
Responsible Party
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David Bartlett
Chief, Division of Surgical Oncology
Principal Investigators
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Herbert J. Zeh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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06-041
Identifier Type: -
Identifier Source: org_study_id