Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies
This study has been terminated.
(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.)
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
First received: April 13, 2010
Last updated: July 31, 2014
Last verified: July 2014
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.
Solid Tumor Malignancies
Biological: Clostridium novyi-NT spores
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of the C. novyi-NT spores will be measured in routine blood sampling over the course of the study. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Experimental: Clostridium novyi-NT spores
Biological: Clostridium novyi-NT spores
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.
- anaerobic bacteria
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
- 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.
- 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:
i. Symptomatic congestive heart failure; ii. Psychiatric Illness/Social Situation that may make study dangerous; and iii. Unstable angina pectoris.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01118819
|Washington University School of Medicine
|St. Louis, Missouri, United States, 63110 |
|Montefiore Medical Center
|Bronx, New York, United States, 10461 |
BioMed Valley Discoveries, Inc
No publications provided
||BioMed Valley Discoveries, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2010
||July 31, 2014
||United States: Food and Drug Administration
Keywords provided by BioMed Valley Discoveries, Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 03, 2015