Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies

Stopped early · Phase 1

Conditions studied: Solid Tumor Malignancies

In brief

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.

Key facts

Study ID

NCT01118819

Run by

BioMed Valley Discoveries, Inc

People needed

5

Starts

2011-04-01

Expected to finish

2013-06-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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