Neoplasm MetastasisPhase 1NCT00327652
Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
A Phase 1 study testing CRS-100 in people with Neoplasm Metastasis and Liver Neoplasms, run by Anza Therapeutics, Inc. at 2 sites in United States.
Trial summary
This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Liver Neoplasms, Carcinoma
- What is being tested?
- CRS-100
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Feb 2008
- 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
- Documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). Hepatocellular carcinoma (HCC) is not allowed.
- Hepatic metastases
- ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to 100%.
- Adequate organ function as defined by clinical hematology and chemistry assays.
Who cannot join
- Known central nervous system metastases.
- History of allergic reactions attributed to sulfa or beta-lactam antibiotics.
- Cardiac conditions associated with high- or moderate-risk of endocarditis.
- Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
- Artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
- Known coagulation disorder or recent thromboembolic event.
Show all 10Show fewer
- Use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to CRS-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
- Current history of gallstones or kidney stones.
- Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus (HCV), or hepatitis b virus (HBV).
- Pregnant or lactating
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Mary Crowley Medical Research Center
Dallas, Texas, 75201
About this study
Official title: Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of the investigational agent to stimulate immunity in test animals and generate anti-tumor activity in mice. The primary objective of this study was to determine the maximum tolerated dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in consenting volunteers. Immunological response to CRS-100 and tumor status of study participants were also measured. Participation in this first clinical trial with CRS-100 was restricted to adults with carcinoma refractory to standard treatment (or for whom no standard treatment is available) and who additionally had liver metastases.
Read the detailed description
Patients who consented to participate in the study were 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 qualified for the study received a single intravenous dose of CRS-100 on study day 1, after which they remained in the hospital for five days for safety monitoring of health status, including serial blood collections. Study participants returned for out-patient follow-up for further blood tests and additional monitoring of safety and immune response to CRS-100. At day 56, after administration of CRS-100, participants had a repeat CT scan to measure tumor size, and they were then discharged from the study.
- Conditions
- Neoplasm Metastasis, Liver Neoplasms, Carcinoma
- Being tested
- CRS-100
- Keywords
- carcinoma, liver, hepatic, metastasis, Listeria
- Medical subject headings
- Neoplasm Metastasis, Liver Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRS-100Drug
Live-attenuated Listeria monocytogenes
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs) for 7 days after dosing
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startOct 2006
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anza Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327652
- Sponsor's protocol ID
- VAC05001
- Status last verified
- Apr 2008
- First submitted
- 17 May 2006
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
- ClinicalTrials.gov ID
- NCT00327652
- Acronym / sponsor ID
- VAC05001
- Conditions
- Neoplasm Metastasis, Liver Neoplasms, Carcinoma
- Keywords
- carcinoma, liver, hepatic, metastasis, Listeria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Anza Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Feb 2008 (actual)
- First posted
- 18 May 2006 (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 clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of the investigational agent to stimulate immunity in test animals and generate anti-tumor activity in mice. The primary objective of this study was to determine the maximum tolerated dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in consenting volunteers. Immunological response to CRS-100 and tumor status of study participants were also measured. Participation in this first clinical trial with CRS-100 was restricted to adults with carcinoma refractory to standard treatment (or for whom no standard treatment is available) and who additionally had liver metastases.
Detailed description
Patients who consented to participate in the study were 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 qualified for the study received a single intravenous dose of CRS-100 on study day 1, after which they remained in the hospital for five days for safety monitoring of health status, including serial blood collections. Study participants returned for out-patient follow-up for further blood tests and additional monitoring of safety and immune response to CRS-100. At day 56, after administration of CRS-100, participants had a repeat CT scan to measure tumor size, and they were then discharged from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). Hepatocellular carcinoma (HCC) is not allowed.
- Hepatic metastases
- ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to 100%.
- Adequate organ function as defined by clinical hematology and chemistry assays.
Key exclusion criteria (10 listed)
- Known central nervous system metastases.
- History of allergic reactions attributed to sulfa or beta-lactam antibiotics.
- Cardiac conditions associated with high- or moderate-risk of endocarditis.
- Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
- Artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
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 |
|---|---|---|
| CRS-100Live-attenuated Listeria monocytogenes | Drug | – |
Primary outcome
Dose-limiting toxicities (DLTs) for 7 days after dosing
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
Related trials for Neoplasm Metastasis
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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 CRS-100 in people with Neoplasm Metastasis and Liver Neoplasms, run by Anza Therapeutics, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 24 Apr 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicities (DLTs) for 7 days after dosing (time frame: 7 days). 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 24 Apr 2008.