Solid Tumor MalignanciesPhase 1NCT01118819
Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies
A Phase 1 study testing Clostridium novyi-NT spores in people with Solid Tumor Malignancies, run by BioMed Valley Discoveries, Inc at 2 sites in United States.
Trial summary
This protocol will examine the safety of intravenous administration of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- Clostridium novyi-NT spores
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jun 2013
- 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
- Diagnosis of an advanced solid tumor malignancy
- History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment.
- Measurable disease as defined by RECIST 1.1 criteria.
- At least 4 weeks has elapsed since the completion of major surgery and the patient is fully recovered from this surgery and any post-surgical complications.
- ECOG performance status of 2 or less.
- Patient is at least 18 years of age
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- Patient is capable of giving informed consent.
- Patient of childbearing potential (defined by the clinical sites' standards) is using adequate birth control measures (e.g., barrier method with spermicide; intrauterine device; implantable or injectable hormonal contraceptives; surgical sterilization) for the duration of the study and will continue to use such precautions for 12 months after receiving treatment.
- Patient has no significant valvular disease (trace or mild valvular stenosis or regurgitation is allowed).
- Patient is able to stay within 45 minutes driving time of an emergency room for 28 days following discharge.
- The patient has a caregiver for 28 days after dosing.
Who cannot join
- Positive pregnancy test
- Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.
- Patient has any of the following hematologic parameters: Platelet count equal to or less than 100,000/mm3, Hemoglobin less than 9.0 g/dL, or an ANC less than 1,000 /mm3.
- Oxygen saturation (Sp02) of less than 95% on room air.
- Mean arterial blood pressure of less than 70 mmHg.
- Glasgow Coma Score of less than 15.
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- Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug.
- Documented evidence of primary brain malignancy or brain metastases.
- Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
- Laboratory evidence of hepatic dysfunction indicated by any of the following: bilirubin > 1.5 x the upper limit of normal, AST or ALT above 2.5X the upper limit of normal, alkaline phosphatase above 2.5X the upper limit of normal or an INR greater than 1.3.
- Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).
- Clinically significant pleural effusion.
- Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
- Need for ongoing treatment with an immunosuppressive agent.
- History of solid organ transplantation (with the exception of a corneal transplant > 3 months prior to screening).
- History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack, or clinically significant peripheral vascular disease).
- Patient has a history of venous stasis resulting in venous stasis ulcers or > 2+ edema.
- History of a significant medical illness deemed by the principal investigator or local investigators as unsuitable for the trial - for example:
- Symptomatic congestive heart failure; ii. Psychiatric Illness/Social Situation that may make study dangerous; and iii. Unstable angina pectoris.
- Asplenia.
- Antibiotic allergies which would preclude treatment for a C. novyi-NT infection, in the event that antibiotics are required.
- Treatment with antibiotics within 2 weeks (14 days) of dosing.
- Active and clinically significant systemic or localized infection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
This protocol will examine the safety of intravenous administration of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intravenously in patients with treatment-refractory solid tumor malignancies.
- Conditions
- Solid Tumor Malignancies
- Being tested
- Clostridium novyi-NT spores
- Keywords
- Phase I, Metastatic Disease, Solid Tumor, Malignancy, Metastases, Clinical trial, Hypoxia, Necrosis
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, Hypoxia, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium novyi-NT sporesBiological
Also called bacteria, anaerobic bacteria
Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 X 10(5) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(5) spores/kg.
| Study group | Role | What they receive |
|---|---|---|
| Clostridium novyi-NT spores | Experimental | Not described Receives: Biological: Clostridium novyi-NT spores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of C. novyi-NT spore administration in patients with advanced solid tumor malignancies will be measured over a 7-day inpatient admission with routine labs and continuous adverse event assessments.
Measured: 2 years
Secondary outcomes (3)
Anti-tumor activity of C. novyi-NT spores will be assessed with serial imaging studies such as CT scans and blood-based tumor markers.
Measured: 2 years
Pharmacokinetics of the C. novyi-NT spores will be measured in routine blood sampling over the course of the study.
Measured: 2 years
The host immune and inflammatory response to C. novyi-NT spores will be measured in routine blood sampling over the course of the study.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: This study was terminated. An IT injection study of C. novyi-NT in patients with treatment refractory solid tumor malignancies may be viewed at NCT01924689.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMed Valley Discoveries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118819
- Sponsor's protocol ID
- BVDCNV1
- Other IDs
- J08107
- Status last verified
- Jan 2016
- First submitted
- 13 Apr 2010
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT01118819
- Acronym / sponsor ID
- BVDCNV1
- Conditions
- Solid Tumor Malignancies
- Keywords
- Phase I, Metastatic Disease, Solid Tumor, Malignancy, Metastases, Clinical trial, Hypoxia, Necrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated. An IT injection study of C. novyi-NT in patients with treatment refractory solid tumor malignancies may be viewed at NCT01924689.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BioMed Valley Discoveries, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 May 2010 (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.
This protocol will examine the safety of intravenous administration of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intravenously in patients with treatment-refractory solid tumor malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clostridium novyi-NT spores | Experimental | Biological: Clostridium novyi-NT spores |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of an advanced solid tumor malignancy
- History of prior treatment with at least one line of systemic anticancer therapy, when an approved systemic therapy is available, and no curative option is available for continued treatment.
- Measurable disease as defined by RECIST 1.1 criteria.
- At least 4 weeks has elapsed since the completion of major surgery and the patient is fully recovered from this surgery and any post-surgical complications.
- ECOG performance status of 2 or less.
Key exclusion criteria (23 listed)
- Positive pregnancy test
- Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.
- Patient has any of the following hematologic parameters: Platelet count equal to or less than 100,000/mm3, Hemoglobin less than 9.0 g/dL, or an ANC less than 1,000 /mm3.
- Oxygen saturation (Sp02) of less than 95% on room air.
- Mean arterial blood pressure of less than 70 mmHg.
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 |
|---|---|---|
| Clostridium novyi-NT sporesAlso: bacteria, anaerobic bacteriaPhase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 X 10(5) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(5) spores/kg. | Biological | Clostridium novyi-NT spores |
Primary outcome
Safety and tolerability of C. novyi-NT spore administration in patients with advanced solid tumor malignancies will be measured over a 7-day inpatient admission with routine labs and continuous adverse event assessments.
Time frame: 2 years
3 secondary outcomes
Anti-tumor activity of C. novyi-NT spores will be assessed with serial imaging studies such as CT scans and blood-based tumor markers.
Time frame: 2 years
Pharmacokinetics of the C. novyi-NT spores will be measured in routine blood sampling over the course of the study.
Time frame: 2 years
The host immune and inflammatory response to C. novyi-NT spores will be measured in routine blood sampling over the course of the study.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: This study was terminated. An IT injection study of C. novyi-NT in patients with treatment refractory solid tumor malignancies may be viewed at NCT01924689.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 Clostridium novyi-NT spores in people with Solid Tumor Malignancies, run by BioMed Valley Discoveries, Inc at 2 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 11 inclusion and 23 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: stopped early, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: This study was terminated. An IT injection study of C. novyi-NT in patients with treatment refractory solid tumor malignancies may be viewed at NCT01924689.). 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?
Safety and tolerability of C. novyi-NT spore administration in patients with advanced solid tumor malignancies will be measured over a 7-day inpatient admission with routine labs and continuous adverse event assessments. (time frame: 2 years). 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 20 Jan 2016.