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Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment

Primary Purpose

Malignant Epithelial Mesothelioma, Adenocarcinoma of the Pancreas, Carcinoma, Non-Small-Cell Lung

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin
Sponsored by
Anza Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Epithelial Mesothelioma focused on measuring Cancer, Ovarian cancer, Pancreatic cancer, Non-small cell lung cancer, Mesothelioma, Mesothelin, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Documented malignant epithelial mesothelioma, cancer of the pancreas or ovaries or non-small-cell lung cancer (NSCLC) and who have failed (or are not candidates for) standard therapy
  2. ECOG Performance Status of 0 to 1, or Karnofsky Performance Status (KPS) of 80-100%
  3. Adequate organ function as defined by study-specified laboratory tests
  4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  5. Signed informed consent form
  6. Willing and able to comply with study procedures

Exclusion Criteria:

  1. History of infection with Listeria, prior vaccination with a listeria-based vaccine, or a positive fecal culture of Listeria at screening
  2. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
  3. Allergy to penicillin or yeast or other component of the study drug product (e.g., glycerol)
  4. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  5. Artificial (prosthetic) joint or other artificial implant or devices that cannot be easily removed
  6. Certain types of blood transfusions within 14 days prior to receiving study drug or a condition requiring regular blood transfusions more than twice per month

  7. Taking the following medications:

    • Anti-coagulation medications
    • Systemically active steroids for more than 2 days within 28 days prior to receiving study drug
    • More than 325 mg per day of aspirin
    • More than 2 g per day of acetaminophen
    • Systemic antibiotics within 14 days prior to receiving study drug
    • Another investigational product within 28 days prior to receiving study drug
  8. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
  9. Infection with HIV, hepatitis B or C, or HTLV-1 (human t-lymphotropic virus type 1) at screening
  10. Pregnant or lactating, or close contact with pregnant women or newborn babies
  11. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Sites / Locations

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
  • National Cancer Institute, NCI
  • University of Pennsylvania Abramson Family Cancer Research Center
  • Hadassah Hebrew University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CRS-207

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicities related to the investigational agent

Secondary Outcome Measures

Full Information

First Posted
December 22, 2007
Last Updated
February 19, 2009
Sponsor
Anza Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00585845
Brief Title
Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment
Official Title
A Phase 1, Open-Label, Dose-Escalation, Multiple Dose Study of the Safety, Tolerability, and Immune Response of CRS-207 in Adult Subjects With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Anza Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has also been genetically modified with recombinant DNA to release an antigen called Mesothelin. Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at higher levels on tumor cells than on normal cells, this clinical trial will also examine if CRS 207 boosts the immune system in a way that targets certain types of cancer. The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of the investigation agent for later clinical studies and to explore safety when given to consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer, or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor status of study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria and must have previously failed standard treatment for their cancer. Qualifying study patients will be assigned to receive one of several dose levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days apart) of CRS-207 at their assigned dose level.
Detailed Description
Patients who consent to participate in the study will be evaluated for eligibility according to their medical history, physical examination, blood testing, and computed tomography (CT) scan of thorax, abdomen, and pelvis. Those patients who qualify for the study will receive up to 4 intravenous doses of CRS-207, 21 days apart. After each infusion, they will be monitored overnight in an in-patient facility, including collection of blood specimens. Study participants will return after each infusion for outpatient follow-up visits for further blood tests and additional monitoring of safety and immune response to CRS-207. Participants will have repeat CT scans to measure tumor size after the 2nd dose and again after the 4th dose. On Day 91 participants will be discharged from the study. All study participants will be eligible to participate in a long-term follow-up study with a visit 6 months after the final dose of CRS-207 and annually thereafter for evaluation of disease progression, survival, and potential long-term toxicity of CRS 207.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Epithelial Mesothelioma, Adenocarcinoma of the Pancreas, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of the Ovaries
Keywords
Cancer, Ovarian cancer, Pancreatic cancer, Non-small cell lung cancer, Mesothelioma, Mesothelin, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRS-207
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin
Intervention Description
2-hour IV infusion once every 21 days, up to 4 doses. Doses from 1x10^8 cfu to 1x10^10 cfu.
Primary Outcome Measure Information:
Title
Dose-limiting toxicities related to the investigational agent
Time Frame
28 days after first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented malignant epithelial mesothelioma, cancer of the pancreas or ovaries or non-small-cell lung cancer (NSCLC) and who have failed (or are not candidates for) standard therapy ECOG Performance Status of 0 to 1, or Karnofsky Performance Status (KPS) of 80-100% Adequate organ function as defined by study-specified laboratory tests Must use acceptable form of birth control through the study and for 28 days after final dose of study drug Signed informed consent form Willing and able to comply with study procedures Exclusion Criteria: History of infection with Listeria, prior vaccination with a listeria-based vaccine, or a positive fecal culture of Listeria at screening Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions Allergy to penicillin or yeast or other component of the study drug product (e.g., glycerol) Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 Artificial (prosthetic) joint or other artificial implant or devices that cannot be easily removed Certain types of blood transfusions within 14 days prior to receiving study drug or a condition requiring regular blood transfusions more than twice per month Taking the following medications: Anti-coagulation medications Systemically active steroids for more than 2 days within 28 days prior to receiving study drug More than 325 mg per day of aspirin More than 2 g per day of acetaminophen Systemic antibiotics within 14 days prior to receiving study drug Another investigational product within 28 days prior to receiving study drug Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia Infection with HIV, hepatitis B or C, or HTLV-1 (human t-lymphotropic virus type 1) at screening Pregnant or lactating, or close contact with pregnant women or newborn babies Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dung Thai
Organizational Affiliation
Anza Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
National Cancer Institute, NCI
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
University of Pennsylvania Abramson Family Cancer Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment

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