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A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer Clinical research trials and A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer. A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer  A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer
A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer
For Condition: Neoplasm Metastasis - Phase II,Breast Neoplasms - Phase I
Status: No longer recruiting
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: Patients with metastatic breast cancer (by American Joint Committee on Cancer staging criteria) who have been shown to be either Her2/neu 3+ by immunohistochemistry (IHC) or FISH-positive, and in whom the investigator has decided to treat with Herceptin® will be included.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: INCLUSION - Women > 18 years of age - Histologically confirmed breast cancer with metastases - Tumor that has overexpression of HER2 as documented by being either FISH-positive or HER2/neu 3+ confirmed by immunohistochemistry - eligible for Herceptin® therapy as a single agent. - Up to three prior chemotherapy regimens for metastatic disease Phase II only: - Must have measurable disease by RECIST criteria (defined in section 8) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques, or as > 10 mm with spiral CT scan - ECOG performance status of 0, 1 or 2 - Life expectancy of greater than 3 months - Neutrophils ³1,500/uL - Platelets ³ 100,000/uL - Creatinine < 2mg/dL - Bilirubin < 2mg/dL - Transaminase < 2 times ULN EXCLUSION A patient must not be enrolled in the study, if any of the following criteria are met: - Acute infection or fever over 38.2o Celsius within 3 days prior to study entry - Any prior therapy with anthracycline + Herceptin® concurrently - Significant cardiovascular disease (e.g., NYHA class 3 congestive heart failure, myocardial infarction within the past 6 months, unstable angina; coronary angioplasty within the past 6 months, uncontrolled atrial or ventricular cardiac arrhythmias) or left ventricular ejection fraction < 50% - Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia - History of allergic reactions attributed to compounds of similar composition to CpG 7909 and/or Herceptin® other than a mild hypersensitivity reaction commonly associated with the first infusion of HerceptinÒ - Present significant renal, hepatic or pulmonary disease - Known CNS metastases treated within 2 months of Day 1 or any uncontrolled CNS metastases - Treatment with the following medications: Treatment with systemic corticosteroids within 4 week prior to the first dose of CpG 7909 Immunostimulatory or immunosuppressive medications Monoclonal Antibodies, except Herceptin® Chemotherapy within 4 weeks of Day 1 Radiation therapy within 4 weeks of Day 1 Ongoing hormonal therapy that was initiated within 8 weeks of Day 1 Chloroquine within 12 weeks of Day 1 - Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with participation in the study, or to interfere with the interpretation of the results - Suspected or confirmed poor compliance or mental instability that may affect the patient’s ability to sign the informed consent and undergo study procedures - Participation in an investigational drug trial within 30 days prior to screening - Patients who have not recovered from adverse events due to agents administered more than 30 days prior to study entry - Lactating at time of study entry - History of allogeneic transplants - Known history of Hepatitis B or C (active, prior treated, or both) - Known History of HIV
Total Enrollment: 64
Location and Contact Information:
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Additional Information:
Study ID Numbers: C015;
Study Start Date: July 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043394
Other Neoplasm Metastasis - Phase Ii Studies:
1. A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer
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Other Neoplasm Metastasis - Phase II Clinical Trials
Other Michigan Clinical Trials
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A Phase I/II Open Label, Multi-Center Dose-Escalation Study of s.c. CpG 7909 plus Herceptin in Patients with Metastatic Breast Cancer
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