MelanomaPhase 1NCT00574977
Safety Study of Modified Vaccinia Virus to Cancer
A Phase 1 study testing Vaccinia virus (vvDD-CDSR) in people with Melanoma and Breast Cancer, run by David Bartlett at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and maximum tolerated dose from injecting this vaccinia virus into tumors or infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Breast Cancer, Head and Neck Squamous Cell Cancer
- What is being tested?
- Vaccinia virus (vvDD-CDSR)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase I Dose-escalation Trial of vvDD-CDSR (Double-deleted Vaccinia Virus Plus CD/ SMR) Administered by Intratumoral Injection or Intravenous Injection
The purpose of this study is to determine the safety and maximum tolerated dose from injecting this vaccinia virus into tumors or infusion.
Read the detailed description
This is a Phase I, open-label, single dose, dose-escalation trial in subjects with melanoma, breast cancer, or head and neck squamous cell cancer, liver, colorectal or pancreatic adenocarinoma. The intratumoral subjects will be stratified into 2 groups. Group A includes those who have been vaccinated with vaccinia virus. A history of vaccination and a scar at vaccination site is required. Group B subjects will include those who have not been vaccinated. It is expected that the toxicity profile will be quite different between those who have been vaccinated previously with vaccinia virus and therefore subjects will be stratified separately in this Phase I trial. All subjects who have refractory tumors will receive treatment at one of five dose levels in a single dose sequential dose-escalating design. 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.
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
- Melanoma, Breast Cancer, Head and Neck Squamous Cell Cancer, Liver Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma
- Being tested
- Vaccinia virus (vvDD-CDSR)
- Keywords
- vaccinia, virus, tumor, melanoma, breast cancer, squamous cell cancer, colorectal, liver, pancreatic, adenocarcinoma
- Medical subject headings
- Melanoma, Breast Neoplasms, Liver Neoplasms, Colorectal Neoplasms, Vaccinia, Virus Diseases, Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccinia virus (vvDD-CDSR)Biological
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)Biological
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)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects who have been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection Receives: Biological: Vaccinia virus (vvDD-CDSR) |
| B | Experimental | Subjects will include those who have not been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection. Receives: Biological: Vaccinia virus (vvDD-CDSR) |
| C | Experimental | Subjects will be those who have been vaccinated with vaccinia virus (small pox)and will be receiving the vvCD-CDSR via intravenous infusion Receives: Biological: Vaccinia virus (vvDD-CDSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (3)
Replication/pharmacokinetics of vvDD-CDSR
Measured: 28 days
Immune response to vvDD-CDSR and to the tumor following administration
Measured: 28 days
Antitumoral efficacy of vvDD-CDSR
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startMay 2008
- Primary completionJan 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Bartlett
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Bartlett, University of Pittsburgh
- Investigators
- Herbert J. Zeh, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574977
- Sponsor's protocol ID
- 06-041
- Status last verified
- Dec 2015
- First submitted
- 13 Dec 2007
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation Trial of vvDD-CDSR (Double-deleted Vaccinia Virus Plus CD/ SMR) Administered by Intratumoral Injection or Intravenous Injection
- ClinicalTrials.gov ID
- NCT00574977
- Acronym / sponsor ID
- 06-041
- Conditions
- Melanoma, Breast Cancer, Head and Neck Squamous Cell Cancer, Liver Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma
- Keywords
- vaccinia, virus, tumor, melanoma, breast cancer, squamous cell cancer, colorectal, liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- David BartlettUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and maximum tolerated dose from injecting this vaccinia virus into tumors or infusion.
Detailed description
This is a Phase I, open-label, single dose, dose-escalation trial in subjects with melanoma, breast cancer, or head and neck squamous cell cancer, liver, colorectal or pancreatic adenocarinoma. The intratumoral subjects will be stratified into 2 groups. Group A includes those who have been vaccinated with vaccinia virus. A history of vaccination and a scar at vaccination site is required. Group B subjects will include those who have not been vaccinated. It is expected that the toxicity profile will be quite different between those who have been vaccinated previously with vaccinia virus and therefore subjects will be stratified separately in this Phase I trial. All subjects who have refractory tumors will receive treatment at one of five dose levels in a single dose sequential dose-escalating design. 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Vaccinia virus (vvDD-CDSR)Subjects who have been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection |
| B | Experimental | Biological: Vaccinia virus (vvDD-CDSR)Subjects will include those who have not been vaccinated with vaccinia virus (small pox)and will receive vvDD-CDSR by intratumoral injection. |
| C | Experimental | Biological: Vaccinia virus (vvDD-CDSR)Subjects will be those who have been vaccinated with vaccinia virus (small pox)and will be receiving the vvCD-CDSR via intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | A |
| 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. | Biological | B |
| 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. | Biological | C |
Primary outcome
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.
Time frame: 28 days
3 secondary outcomes
Replication/pharmacokinetics of vvDD-CDSR
Time frame: 28 days
Immune response to vvDD-CDSR and to the tumor following administration
Time frame: 28 days
Antitumoral efficacy of vvDD-CDSR
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert J. Zeh, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccinia virus (vvDD-CDSR) in people with Melanoma and Breast Cancer, run by David Bartlett at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.