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Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer Clinical research trials and Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer. Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer clinical trial. Participants typically obtain the most effective healthcare available for their Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer  Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer
Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer
For Condition: Breast Neoplasms,Neoplasm Metastasis
Status: Completed
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: The purpose of this study is to determine if the combination of CpG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.
Details: RATIONALE: There is preclinical data that supports the hypothesis that CpG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CpG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy. SCHEDULE: Patients will receive CpG 7909 weekly for up to six months.
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 - Signed Informed Consent Form - Histologically confirmed breast cancer with metastases - Tumor that has overexpression of HER2 - Progression of disease documented during therapy consisting of Herceptin plus chemotherapy. Patients must have received at least one Herceptin/chemotherapy regimen as treatment for metastatic breast cancer. May have had up to two prior chemotherapy regimens for metastatic disease - Disease progression must have occurred after 4 weeks of chemotherapy plus Herceptin. - The interval between the last dose of failed treatment and Day 0 is not to exceed 42 days. - 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 - Negative pregnancy test and agree to use an effective form of birth control during the study - Life expectancy of greater than 3 months. - Neutrophils >1,500/uL - Platelets >100,000/uL - Creatinine <2mg/dL - Bilirubin <2mg/dL - Transaminase <2 times ULN EXCLUSION - Acute infection or fever over 38.2 degrees Celsius within 3 days prior to study entry - Any prior therapy with anthracycline+Herceptin - Significant cardiovascular disease - Pre-existing autoimmune or antibody-mediated diseases - History of allergic reactions attributed to compounds of similar composition to CpG 7909 and/or Herceptin - Present significant renal, hepatic or pulmonary disease - Known CNS metastases treated within 2 months of day 0 or any uncontrolled CNS metastases - Treatment with Anticoagulants (not including salicylates, a Heparin flush or low-dose warfarin used to maintain line patency) or systemic corticosteroids (within one week prior to first dose of CpG 7909) - Medical History likely to interfere with participation or study results - Suspected or confirmed poor compliance or mental instability that may effect ability to grant informed consent or undergo study procedures - Participation in an investigational drug trial within 30 days prior to screening - Lactating at time of study entry - Recipients of (allogeneic) transplants
Total Enrollment: 58
Location and Contact Information:
Overall Study Official:
HaroldBurstein, Principal Investigator, Dana-Farber/Harvard Cancer Center
Cancer Center at Saint Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Cancer Research Network, Inc.
Plantation, Florida, 33324
United States
Greenebaum Cancer Center at Univ. of Maryland
Baltimore, Maryland, 21201
United States
Univ. of Connecticut Health Center
Farmington, Connecticut, 06030
United States
Univ. of Pittsburgh Cancer Institute, Magee Women's Hosp.
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: C005;
Study Start Date: October 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031278
Other Breast Neoplasms Studies:
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2. A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) with Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver
3. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
4. A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833
5. Immunization of Patients with Metastatic Melanoma Using Immunodominant Peptides from the Tyrosinase Protein, Tyrosinase Related Protein-1 (TRP1), or GP100 Protein
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Safety and efficacy study of the combination of CpG 7909 and Herceptin in patients with metastatic breast cancer
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