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Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

Phase 1
18 Years
Not Enrolling
Neoplasm Metastasis, Liver Neoplasms, Carcinoma

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Trial Information

Phase 1 Dose-Escalation Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

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.

Inclusion Criteria

Inclusion Criteria (abbreviated):

1. Documented carcinoma refractory to standard treatment (or for whom no standard
treatment is available). Hepatocellular carcinoma (HCC) is not allowed.

2. Hepatic metastases

3. ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to

4. Adequate organ function as defined by clinical hematology and chemistry assays.

Exclusion Criteria (abbreviated):

1. Known central nervous system metastases.

2. History of allergic reactions attributed to sulfa or beta-lactam antibiotics.

3. Cardiac conditions associated with high- or moderate-risk of endocarditis.

4. Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.

5. Artificial (prosthetic) joint or other artificial implant or devices that cannot
easily be removed.

6. Known coagulation disorder or recent thromboembolic event.

7. 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.

8. Current history of gallstones or kidney stones.

9. Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus
(HCV), or hepatitis b virus (HBV).

10. Pregnant or lactating

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities (DLTs) for 7 days after dosing

Outcome Time Frame:

7 days

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

  • Neoplasm Metastasis
  • Liver Neoplasms
  • Carcinoma
  • carcinoma
  • liver
  • hepatic
  • metastasis
  • Listeria
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary



Johns Hopkins University Baltimore, Maryland  21205
Mary Crowley Medical Research Center Dallas, Texas  75246