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

• ClinicalTrials.gov Identifier: NCT01118819
• Recruitment Status: Terminated
• First Posted: May 7, 2010
• Last Update Posted: January 20, 2016
• Sponsor: BioMed Valley Discoveries, Inc
• Information provided by (Responsible Party): BioMed Valley Discoveries, Inc

Tracking Information

• First Submitted Date: April 13, 2010
• First Posted Date: May 7, 2010
• Last Update Posted Date: January 20, 2016
• Study Start Date: April 2011
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 14, 2011): 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 ]
• Original Primary Outcome Measures (submitted: May 5, 2010): Safety and tolerability of C. novyi-NT spore 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: 4 years ]

Current Secondary Outcome Measures (submitted: April 14, 2011)

• 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 ]

Original Secondary Outcome Measures (submitted: May 5, 2010)

• Anti-tumor activity of C. novyi-NT spores will assessed with serial imaging studies such as CT scans and blood-based tumor markers. [ Time Frame: 4 years ]
• Pharmacokinetics of the C. novyi-NT spores will be measured in routine blood sampling over the course of the study. [ Time Frame: 4 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: 4 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies
• Official Title: Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies
• Brief 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. novyi-NT administered intravenously in patients with treatment-refractory solid tumor malignancies.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumor Malignancies

Intervention

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.

Other Names:

• bacteria
• anaerobic bacteria

Study Arms

Experimental: Clostridium novyi-NT spores

Intervention: Biological: Clostridium novyi-NT spores

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 13, 2014): 5
• Original Estimated Enrollment (submitted: May 5, 2010): 10
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Diagnosis of an advanced solid tumor malignancy
2. 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.
3. Measurable disease as defined by RECIST 1.1 criteria.
4. 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.
5. ECOG performance status of 2 or less.
6. Patient is at least 18 years of age
7. Patient is capable of giving informed consent.
8. 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.
9. Patient has no significant valvular disease (trace or mild valvular stenosis or regurgitation is allowed).
10. Patient is able to stay within 45 minutes driving time of an emergency room for 28 days following discharge.
11. The patient has a caregiver for 28 days after dosing.

Exclusion Criteria:

1. Positive pregnancy test
2. Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.
3. 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.
4. Oxygen saturation (Sp02) of less than 95% on room air.
5. Mean arterial blood pressure of less than 70 mmHg.
6. Glasgow Coma Score of less than 15.
7. Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug.
8. Documented evidence of primary brain malignancy or brain metastases.
9. Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
10. 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.
11. 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).
12. Clinically significant pleural effusion.
13. Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
14. Need for ongoing treatment with an immunosuppressive agent.
15. History of solid organ transplantation (with the exception of a corneal transplant > 3 months prior to screening).
16. 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).
17. Patient has a history of venous stasis resulting in venous stasis ulcers or > 2+ edema.

18. 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.

19. Asplenia.
20. Antibiotic allergies which would preclude treatment for a C. novyi-NT infection, in the event that antibiotics are required.
21. Treatment with antibiotics within 2 weeks (14 days) of dosing.
22. Active and clinically significant systemic or localized infection.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01118819
• Other Study ID Numbers: BVDCNV1; J08107 ( Other Identifier: Previous Sponsor )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: BioMed Valley Discoveries, Inc
• Original Responsible Party: Luis A Diaz, M.D., The Sidney Kimmel Comprehensive Cancer Center
• Current Study Sponsor: BioMed Valley Discoveries, Inc
• Original Study Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: BioMed Valley Discoveries, Inc
• Verification Date: January 2016