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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Epithelial Mesothelioma, Adenocarcinoma of the Pancreas, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of the Ovaries

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicities related to the investigational agent

Outcome Time Frame:

28 days after first dose

Safety Issue:

Yes

Principal Investigator

Dung Thai

Investigator Role:

Study Director

Investigator Affiliation:

Anza Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

VAC07001

NCT ID:

NCT00585845

Start Date:

December 2007

Completion Date:

February 2009

Related Keywords:

  • Malignant Epithelial Mesothelioma
  • Adenocarcinoma of the Pancreas
  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma of the Ovaries
  • Cancer
  • Ovarian cancer
  • Pancreatic cancer
  • Non-small cell lung cancer
  • Mesothelioma
  • Mesothelin
  • Immunotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins UniversityBaltimore, Maryland  21231
National Cancer Institute, NCIBethesda, Maryland  20892
University of Pennsylvania Abramson Family Cancer Research CenterPhiladelphia, Pennsylvania  19104