CarcinoidPhase 1NCT00314925
Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features
A Phase 1 study testing Seneca Valley Virus (biological agent) in people with Carcinoid and Neuroendocrine, run by Neotropix at 10 sites in United States.
Trial summary
The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid, Neuroendocrine
- What is being tested?
- Seneca Valley Virus (biological agent)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2006to Dec 2008
- 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
- Patients must have a histologically confirmed solid tumor (including carcinoid) with neuroendocrine features (i.e., expression of >= 1 of the following 3 markers: synaptophysin, chromogranin A, or CD56) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Patients must show evidence of disease progression in the three months prior to treatment with SVV-001.
- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of SVV-001 in patients <18 years of age, children are excluded from this study. Children may be eligible for future pediatric Phase I single-agent trials.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy >= 24 weeks.
- Adequate bone marrow, hepatic, and renal function as defined below:
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- absolute lymphocyte count >= 1,000/ul
- absolute neutrophil count >= 1,500/ul
- platelets >= 100,000/ul
- AST/ALT <= 2.5 x upper limit of normal (ULN) or <= 5 x ULN if liver metastases present
- total bilirubin <= 1.5 x upper limit of normal
- creatinine <= 1.5 x upper limit of normal OR
- creatinine clearance (calculated) <= 60 mL/min/1.73 m2 for patients with creatinine > 1.5 x upper limit of normal.
- Women must have been surgically sterilized or be post-menopausal.
- Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for up to 6 months.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have oxygen saturation of at least 95% on room air.
- Patients must have measurable disease by RECIST (CT and/or MRI).
Who cannot join
- Patients with small cell histology.
- Patients who have been hospitalized for emergent conditions requiring inpatient evaluation, treatment or procedure during the 30 days prior to entry on study. In addition, emergent conditions requiring inpatient evaluation, treatment or procedure must have resolved or be medically stable and not severe for 30 days prior to entry on study.
- Use of chemotherapy or radiotherapy within 4 weeks of initiation of SVV-001, or continued > Grade 1 adverse events, excluding alopecia, due to agents administered more than 4 weeks earlier.
- Patients with clinically evident Human Immuno-deficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
- Patients with > Grade 1 peripheral neuropathy (CTCAE version 3.0).
- Concurrent use of any other investigational agents.
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- Presence of or history of central nervous system metastasis.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pre-menopausal women who have not been surgically sterilized. Although SVV-001 has no affect on the ovaries from a toxicological perspective, SVV-001 RNA is present in the ovaries at 12 weeks in animals that were administered high and medium doses. No pre-clinical reproductive tests have been conducted with SVV-001.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New York Oncology Hematology P.C.
Albany, New York, 12208
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Mary Crowley Research Center
Dallas, Texas, 75201
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Dayton Oncology & Hematology, P.A .
Kettering, Ohio, 45409
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centers of Florida
Ocoee, Florida, 34761
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, 98684
About this study
Official title: Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features
The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.
Read the detailed description
This is the first study in man of Seneca Valley Virus, a virus which seeks and kills certain tumors in non-human model systems. Subjects in this trial will be patients with advanced cancer displaying certain specified neuroendocrine features, pathologically; they will have exhausted standard methods of treatment for their tumor. The primary purpose of the trial is to determine if the virus may be administered safely. Additional purposes are to learn about the distribution of the virus in the body, the elimination of the virus from the body, the immune response to the virus and whether the virus might have some beneficial effects upon the tumors which the patients have. The first patients will be treated with low amounts of virus and subsequent patients may receive higher amounts. At the end of the trial, it is intended to select a dose for further study.
- Conditions
- Carcinoid, Neuroendocrine
- Being tested
- Seneca Valley Virus (biological agent)
- Keywords
- advanced carcinoma, carcinoid, neuroendocrine features, oncolytic virus, phase I study, dose escalation study, rhabdomyosarcoma, alveolar rhabdomyosarcoma, medulloblastoma, rhabdoid, glioblastoma, ewing's sarcoma, pediatric oncologies, neuroblastoma, wilms' tumor, retinoblastoma, Large cell lung cancer
- Medical subject headings
- Carcinoid Tumor, Rhabdomyosarcoma, Rhabdomyosarcoma, Alveolar, Medulloblastoma, Glioblastoma, Sarcoma, Ewing, Neuroblastoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seneca Valley Virus (biological agent)Drug
Also called SVV-001
Dose escalation (starting at 1 × 10^7 vp/kg), IV (in the vein) over 1 hour in a single administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Seneca Valley Virus (biological agent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity and determination of phase II dose
Measured: Within 28 days of treatment administration
Secondary outcomes (3)
Number of responses according to RECIST criteria
Measured: Baseline; at Week 7, Day 7 following therapy and then confirmation scan at least 4 weeks later, if required; and every 2 months for up to 6 months, if required
Limited pharmacokinetics, biodistribution and elimination
Measured: Until 2 consecutive negative viral assays
Limited evaluation of occurrence of neutralizing antibody
Measured: Baseline and at Week 2, Day 1 following therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarcinoidStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neotropix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rudin Charles, MD, PhD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314925
- Sponsor's protocol ID
- N05-10564
- Status last verified
- Feb 2010
- First submitted
- 13 Apr 2006
- Last updated
- 25 Feb 2010
- Results posted
- No
Publications
Venkataraman S, Reddy SP, Loo J, Idamakanti N, Hallenbeck PL, Reddy VS. Crystallization and preliminary X-ray diffraction studies of Seneca Valley virus-001, a new member of the Picornaviridae family. Acta Crystallogr Sect F Struct Biol Cryst Commun. 2008 Apr 1;64(Pt 4):293-6. doi: 10.1107/S1744309108006921. Epub 2008 Mar 21.
PubMed 18391430
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features
- ClinicalTrials.gov ID
- NCT00314925
- Acronym / sponsor ID
- N05-10564
- Conditions
- Carcinoid, Neuroendocrine
- Keywords
- advanced carcinoma, carcinoid, neuroendocrine features, oncolytic virus, phase I study, dose escalation study, rhabdomyosarcoma, alveolar rhabdomyosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NeotropixIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 17 Apr 2006 (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 primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.
Detailed description
This is the first study in man of Seneca Valley Virus, a virus which seeks and kills certain tumors in non-human model systems. Subjects in this trial will be patients with advanced cancer displaying certain specified neuroendocrine features, pathologically; they will have exhausted standard methods of treatment for their tumor. The primary purpose of the trial is to determine if the virus may be administered safely. Additional purposes are to learn about the distribution of the virus in the body, the elimination of the virus from the body, the immune response to the virus and whether the virus might have some beneficial effects upon the tumors which the patients have. The first patients will be treated with low amounts of virus and subsequent patients may receive higher amounts. At the end of the trial, it is intended to select a dose for further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Seneca Valley Virus (biological agent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have a histologically confirmed solid tumor (including carcinoid) with neuroendocrine features (i.e., expression of >= 1 of the following 3 markers: synaptophysin, chromogranin A, or CD56) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Patients must show evidence of disease progression in the three months prior to treatment with SVV-001.
- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of SVV-001 in patients <18 years of age, children are excluded from this study. Children may be eligible for future pediatric Phase I single-agent trials.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy >= 24 weeks.
Key exclusion criteria (9 listed)
- Patients with small cell histology.
- Patients who have been hospitalized for emergent conditions requiring inpatient evaluation, treatment or procedure during the 30 days prior to entry on study. In addition, emergent conditions requiring inpatient evaluation, treatment or procedure must have resolved or be medically stable and not severe for 30 days prior to entry on study.
- Use of chemotherapy or radiotherapy within 4 weeks of initiation of SVV-001, or continued > Grade 1 adverse events, excluding alopecia, due to agents administered more than 4 weeks earlier.
- Patients with clinically evident Human Immuno-deficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
- Patients with > Grade 1 peripheral neuropathy (CTCAE version 3.0).
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 |
|---|---|---|
| Seneca Valley Virus (biological agent)Also: SVV-001Dose escalation (starting at 1 × 10^7 vp/kg), IV (in the vein) over 1 hour in a single administration | Drug | 1 |
Primary outcome
Incidence of dose-limiting toxicity and determination of phase II dose
Time frame: Within 28 days of treatment administration
3 secondary outcomes
Number of responses according to RECIST criteria
Time frame: Baseline; at Week 7, Day 7 following therapy and then confirmation scan at least 4 weeks later, if required; and every 2 months for up to 6 months, if required
Limited pharmacokinetics, biodistribution and elimination
Time frame: Until 2 consecutive negative viral assays
Limited evaluation of occurrence of neutralizing antibody
Time frame: Baseline and at Week 2, Day 1 following therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
- Derived from this study: PubMed 18391430Venkataraman S, Reddy SP, Loo J, Idamakanti N, Hallenbeck PL, Reddy VS. Crystallization and preliminary X-ray diffraction studies of Seneca Valley virus-001, a new member of the Picornaviridae family. Acta Crystallogr Sect F Struct Biol Cryst Commun. 2008 Apr 1;64(Pt 4):293-6. doi: 10.1107/S1744309108006921. Epub 2008 Mar 21.
- website of sponsorLink provided by the sponsor.
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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.
Rudin Charles, MD, PhD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seneca Valley Virus (biological agent) in people with Carcinoid and Neuroendocrine, run by Neotropix at 10 sites 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 18 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
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?
Incidence of dose-limiting toxicity and determination of phase II dose (time frame: Within 28 days of treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314925, which also lists 1 linked publication.
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 25 Feb 2010.