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Home > "C" Clinical Trials Conditions > CPG 7909 Injection in non-small cell lung cancer  CPG 7909 Injection in non-small cell lung cancer
CPG 7909 Injection in non-small cell lung cancer
For Condition: Carcinoma, Non-Small-Cell Lung
Status: Recruiting
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: This is a randomized, multi-center, Phase 2 trial comparing treatment with CPG 7909 Injection plus chemotherapy or chemotherapy alone in patients with non-small cell lung cancer (NSCLC). Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression. Patients will remain on study until the development of objective tumor progression.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC, Appendix D) - Patients must have measurable disease according to the RECIST criteria (Appendix F) - Age > 18 years - Karnofsky Performance Status of > 70 - Adequate bone marrow reserve as evidenced by WBC > 3,000/mL, ANC > 1,500/mL, and PLT > 100,000/mL - Adequate renal function as evidenced by serum creatinine < 2.0 mg/dL - Adequate hepatic function as evidenced by serum total bilirubin < 2.0 mg/dL, AST < 5 X ULN for the reference lab - Patients must be recovered from the effects of any prior surgery or radiotherapy - Patients or their legal representatives must be able to understand and provide informed consent to participate in the trial Exclusion Criteria: - Patients with active infection or with a fever >38.50 C within three days prior to the first scheduled day of dosing - Prior treatment with chemotherapy; patients may have received prior radiotherapy - Patients with suspected or known CNS metastases - Prior treatment with etanercept, anakinra, leflunomide, or tacrolimus for any reason - The need for pharmacologic doses of systemic steroids will be excluded; replacement doses, topical or inhalation glucocorticoids are permitted. - Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, etc. - Chloroquine and related compounds within 12 weeks of study entry (1st dose of protocol therapy) - History of other prior malignancy within the past 5 years other than basal cell carcinoma of the skin or cervical intra-epithelial neoplasia, or cured, early prostate cancer in a patient with PSA < 10 ng/mL - Patients with known hypersensitivity to any of the components of CpG 7909 Injection or to any of the components of the taxane or platinum drugs - Patients who have received an investigational therapy within 30 days of study entry (1st dose of protocol therapy) - Serious medical or psychiatric condition, which would hinder the patient’s ability to fully comply with the protocol - Grade 2 peripheral neuropathy - Patients who are pregnant or lactating - Adults of reproductive potential and their partners must agree to use effective contraceptive measures - History of allogeneic transplant - Known HIV - Treatment with hematopoietic growth factors within 4 weeks of the first CpG 7909 Injection
Total Enrollment: 75
Location and Contact Information:
Coley Pharmaceutical Group, Inc. *Recruiting*
Wellesley, Massachusetts, 02481
United States
Recruiting Tess Schmalbach 781-431-9000
Additional Information:
Study ID Numbers: C017; ProMune
Study Start Date: April 2003
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070629
Other Carcinoma, Non-Small-Cell Lung Studies:
1. Comparative Trial of Pivanex and Docetaxel vs Docetaxel Monotherapy in Patients with Advanced Non-Small Cell Lung Cancer
2. Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer
3. A multicenter phase 2 study of CI-1040 in patients with advanced nonsmall-cell lung cancer, breast cancer, colon cancer, or pancreatic cancer
4. Safety and efficacy of ABR-217620 in patients with advanced non-small cell lung cancer.
5. Iressa Expanded Access Program (EAP)
Related Studies:
Other Carcinoma, Non-Small-Cell Lung Clinical Trials
Other Massachusetts Clinical Trials
Other Wellesley Clinical Trials
CPG 7909 Injection in non-small cell lung cancer
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