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Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies 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 Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies Clinical research trials and Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies 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 Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies. Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies 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 Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies clinical trial. Participants typically obtain the most effective healthcare available for their Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies 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 > "C" Clinical Trials Conditions > Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies  Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies
Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies
For Condition: Neoplasm Metastasis
Status: Recruiting
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: Inclusion: Immediate prior completion of a clinical trial of CpG 7909 alone or in combination with other anti-neoplastic treatment for metastatic malignancy. Patients may only enroll in the Continuation Study C016 immediately following completion of another trial of CpG 7909 for the treatment of malignant disease. Patients must have metastatic or recurrent malignancy, or malignant disease for which there is no curative therapy and an ECOG Performance Status < 2 Exclusion: The patient has received any anti-neoplastic therapy since completing a prior trial with CpG 7909, or has participated in another clinical trial following participation in a trial with CpG 7909. Women who are pregnant, lactating or unable/unwilling to use contraception will be excluded.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION 1. Immediate prior completion of a clinical trial of CpG 7909 alone or in combination with other anti-neoplastic treatment for metastatic malignancy. Patients may only enroll in Study C016 immediately following completion of another trial of CpG 7909 for the treatment of malignant disease. 2. Metastatic or recurrent malignancy, or malignant disease for which there is no curative therapy. 3. ECOG Performance Status < 2 4. > 18 years of age 5. Adequate bone marrow reserve: WBC > 4,000mm3; hemoglobin ³ 10 g/dl; platelet count > 100,000 mm3; neutrophils > 1000/ μL 6. Adequate renal function: serum creatinine 90% reliability) form of birth control during the study and for 4 weeks following the last study drug administration 10. Women of reproductive potential: negative pregnancy test (urine and/or serum β-hCG). 11. Signed Informed Consent Form 12. Able to comply with the treatment schedule EXCLUSION 1. Pre-existing autoimmune or antibody-mediated diseases including: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease 2. The patient has received any anti-neoplastic therapy since completing a prior trial with CpG, or has participated in another clinical trial following participation in a trial with CpG. 3. Serious infection or illness including human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both) 4. Patients who are more than four weeks from completion of their prior CpG 7909 study. 5. History of allergic reactions attributed to compounds of similar composition to CpG 7909 6. Current anticoagulant therapy (exception, ASA < 325 mg/day allowed) 7. Significant cardiovascular disease (i.e. 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) 8. Breast feeding at time of study entry 9. Suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the Investigator to be likely to effect their ability to sign the informed consent, or undergo study procedures 10. Presentation with, or a recent history (within 24 hours) of a fever > 38.2°C or symptoms of significant local infection or systemic infection, including urinary tract infections – such patients will be deferred from enrollment at least until 48 hours after illness has resolved 11. Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results
Total Enrollment: 50
Location and Contact Information:
St. Barnabas Medical Center *Recruiting*
Livingston, New Jersey, 07039
United States
Recruiting Richard Michaelson 973-322-5362
Additional Information:
Study ID Numbers: C016;
Study Start Date: July 2002
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043368
Other Neoplasm Metastasis Studies:
1. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox Virus Encoding a gp100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
2. Studies on Tumors of the Thyroid
3. A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients with Metastatic Renal Cancer
4. Treatment of Patients with Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
5. A Phase I Study of Oral COL-3 (NSC-683551), a Matrix Metalloproteinase Inhibitor, in Patients with Refractory Metastatic Cancer
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other New Jersey Clinical Trials
Other Livingston Clinical Trials
Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies
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