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Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer Clinical research trials and Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer. Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer  Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
For Condition: Post Nephrectomy,Renal Cell Cancer
Status: Recruiting
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: Dose Escalation: 3 patients included in each cohort of CpG 7909 administered subcutaneously. Patients will be treated weekly for up to 24 weeks. If 2 patients experience dose-limiting toxicity (DLT) at any dose, the dose stratum just below it will be considered the maximum tolerated dose (MTD) and will be the dose administered in the Phase II portion of the study. DURATION OF PARTICIPATION PER PATIENT: PHASE II PORTION OF TRIAL STAGE I Additional patients who meet the entrance criteria will be treated weekly for up to 24 weeks (or until disease progression or unacceptable toxicity occurs) with CpG 7909, the dose of which will be determined in the dose escalation portion of the study, administered subcutaneously (SC). DURATION OF PARTICIPATION PER PATIENT: PHASE II PORTION OF TRIAL STAGE 2 If at least one response is achieved in Stage 1, 25 additional eligible patients will be treated with this regimen for a total of 40 patients. Study Objectives: To determine the tolerability of subcutaneously administrated CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer. To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Signed Informed Consent Form - Able to comply with the treatment schedule - Histologically confirmed Stage IV renal-cell carcinoma (AJCC) with lung and/or soft tissue metastases after nephrectomy - ECOG performance status 0 or 1 - Measurable disease by Recist criteria (as defined in Section 8.1) with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques, or as ³ 10 mm with spiral CT scan - > 18 years of age - Must have adequate bone marrow reserve: hemoglobin ³10 g/dL; platelet count > 100,000 mm3 ; neutrophils ³ 1000/ mL - Must have adequate renal function: serum creatinine £ 2.0 mg/dL. - Must have adequate hepatic function: bilirubin £ 1.5 mg/dL; SGOT/SGPT <3x upper limit of normal - Activated partial thromboplastin time £ 40 seconds - Serum calcium within normal limits based on laboratory criteria - Predominant clear cell histology - Patients of reproductive potential must agree to use an effective (>90% reliability) form of birth control during the study and for 4 weeks following the last study drug administration. (All patients and their partners) - Life expectancy of greater than 4 months Exclusion Criteria: - Pre-existing autoimmune or antibody-mediated diseases including: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia. Controlled thyroid disease or the presence of auto-antibodies without clinical autoimmune disease are permissible - Known history of HIV - CNS, bone or liver metastases - Tumors that are mainly papillary, chromophobe, medullary, collecting duct, or unclassified, are to be excluded - Prior malignancy except basal cell or non-invasive squamous cell carcinoma of the skin or in situ squamous cell carcinoma of the cervix - History of allergic reactions attributed to compounds of similar composition to CpG 7909 - 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 less than 40% - Recipients of solid organ allografts - Prior splenectomy - Prior immunotherapy, including IL-2 or IFN-alpha - Any prior therapy for renal cell cancer except for surgery - Prior chemotherapy - Prior radiation therapy to 25 percent or more of the bone marrow - Systemic corticosteroids or immunosuppressants and anticoagulants (except for aspirin £ 325 mg per day) - Acute infection requiring antibiotics and/or fever over 38.2° C within 3 days prior to study entry - Pregnant or lactating - Participation in an investigational drug trial within 30 days prior to screening - 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 - 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, and undergo study procedures - Hepatitis B or C (active, prior treated, or both)
Total Enrollment: 46
Location and Contact Information:
Cleveland Clinic *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Ronald Bukowski 216-445-4217
Additional Information:
Study ID Numbers: C010;
Study Start Date: March 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043407
Other Renal Cell Cancer Studies:
1. Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
Related Studies:
Other Renal Cell Cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Phase I/II Open Label Multi-Center Study of CpG 7909 in Patients with Stage IV Renal Cell Cancer
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