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CPG 7909 in Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on CPG 7909 in Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. CPG 7909 in Melanoma Clinical research trials and CPG 7909 in Melanoma healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including CPG 7909 in Melanoma. CPG 7909 in Melanoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a CPG 7909 in Melanoma clinical trial. Test subjects typically receive the most effective healthcare possible for their CPG 7909 in Melanoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CPG 7909 in Melanoma  CPG 7909 in Melanoma
CPG 7909 in Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: In phase II, 160 eligible patients will be randomized in a balanced allocation to CPG 7909 Injection current dose (10 mg given in two 5 mg injections); CPG 7909 Injection intensified dose (40 mg given in four 10 mg injections); CPG 7909 Injection 40 mg plus DTIC; or DTIC alone. An interim analysis will be performed after 160 patients have completed the cycle 5 tumor burden assessment to determine the optimal two arms, based on overall response rate, to continue to Phase III. Subsequent to the interim analysis, three-hundred-seventy patients will be enrolled into Phase III of the trial in a balanced randomization to two arms; either 1:1 DTIC alone or CPG 7909 monotherapy or 1:1 DTIC alone or CPG 7909 in combination with DTIC. In the monotherapy arms, CPG 7909 Injection will be administered subcutaneously every week. In the combination arm, CPG 7909 Injection will be administered subcutaneously weekly, and chemotherapy will be administered on Week 1 (Day 1) of a three-week cycle. In the DTIC monotherapy arm, patients will receive DTIC on week 1 (Day 1) of a three-week cycle. All patients will undergo complete disease evaluation at the end of the third treatment cycle and then at the end of every other treatment cycle (after cycles 3, 5, 7 etc.) until confirmation of disease progression. Patients will remain on study until the development of objective tumor progression, as defined by RECIST criteria, is confirmed; intolerance to any study medication; or until any other protocol conditions for withdrawal are met.
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 melanoma that is metastatic (unresectable Stage IIIb/c or Stage IV according to AJCC 2002, Appendix D). - Patients must have measurable disease according to the RECIST criteria (Appendix F). A cutaneous or subcutaneous lesion identified as a target lesion must be at least 10 mm in diameter in one dimension. - 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 - LDH 3 times upper limit of normal - 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 anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy which completed at least four weeks prior to Day 1) - Patients with suspected or known CNS metastases - Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia - 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) - Chloroquine and related compounds within 12 weeks of study entry (1st dose of protocol therapy) - Current treatment with phenytoin or phenobarbital - The need for pharmacologic doses of systemic steroids will be excluded; but replacement doses, topical or inhalation glucocorticoids are permitted. - Patients who have received an investigational therapy within 30 days 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 dacarbazine - Serious medical or psychiatric condition, which would hinder the patient’s ability to fully comply with the protocol - Patients who are pregnant or lactating. Adults of reproductive potential and their partners must agree to use effective contraceptive measures - Known HIV
Total Enrollment: 450
Location and Contact Information:
University of Michigan *Not yet recruiting*
Ann Arbor, Michigan, 48109
United States
Not yet recruiting Peg Esper 734-936-8906
Kaiser Group Health *Not yet recruiting*
Portland, Oregon, 97227
United States
Not yet recruiting Mark Rarick 503-249-3329
The West Clinic *Not yet recruiting*
Memphis, Tennessee, 38138
United States
Not yet recruiting Marnie Brotherton 901-683-0055
Hem-Onc Associates of the Treasure Coast *Terminated*
Port St. Lucie, Florida, 34952
United States
Terminated
Florida Oncology Associates *Not yet recruiting*
Jacksonville, Florida, 32201
United States
Not yet recruiting Salahattin Sanal 904-739-7779
Northwestern University *Not yet recruiting*
Chicago, Illinois, 60611
United States
Not yet recruiting Brenda Martone 312-695-1366
Central Baptist Hospital *Recruiting*
Lexington, Kentucky, 40505
United States
Recruiting Diane Houck 859-260-6066
North Shore University Hospital *Not yet recruiting*
Manhasset, New York, 11030
United States
Not yet recruiting Barbara Thiem 516-562-8977
John Wayne Cancer Institute *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Pat Ames 310-998-3973
UC Irvine *Not yet recruiting*
Orange, California, 92868
United States
Not yet recruiting Frank Meyskens 714-456-5077
Oncology Specialists *Not yet recruiting*
Park Ridge, Illinois, 60068
United States
Not yet recruiting Mary Hurd 847-723-8284
Comprehensive Cancer Centers of the Desert *Not yet recruiting*
Palm Springs, California, 92262
United States
Not yet recruiting Cindy Rhody 760-416-4822
University of Pittsburgh Cancer Institute *Not yet recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Not yet recruiting Lori Stover 412-623-3272
Indiana Oncology Hematology Consultants *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Cathy Spears 317-833-1297
Newland Medical Associates *Not yet recruiting*
Southfield, Michigan, 48075
United States
Not yet recruiting Anibal Drelichman 248-528-0650
Greenville CCOP *Not yet recruiting*
Greenville, South Carolina, 29615
United States
Not yet recruiting Joe Stephenson 864-987-7000
Kenmar Research Institute *Not yet recruiting*
Los Angeles, California, 90066
United States
Not yet recruiting Sara Margiotta 213-989-1888
Norris Cancer Center, USC *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Jolie Solomon 323-865-0464
St. Luke's Mountain States Tumor Institute *Recruiting*
Boise, Idaho, 83712
United States
Recruiting Jane Harris 208-381-3132
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Beth Davis 510-204-3428
Saint Francis Memorial Hospital *Not yet recruiting*
San Francisco, California, 94109
United States
Not yet recruiting Robert Weber 415-353-6863
Boston Medical Center *Not yet recruiting*
Boston, Massachusetts, 02118
United States
Not yet recruiting Rebecca Brown 617-414-1828
Cleveland Clinic *Not yet recruiting*
Cleveland, Ohio, 44195
United States
Not yet recruiting Thomas Olencki 216-444-7774
University of California *Terminated*
Los Angeles, California, 90095
United States
Terminated
Lakeland Regional Cancer Center *Not yet recruiting*
Lakeland, Florida, 33805
United States
Not yet recruiting Patricia Gowland 863-603-6565
Georgia Cancer Specialists *Not yet recruiting*
Tucker, Georgia, 30084
United States
Not yet recruiting Mansoor Saleh 770-496-9428
University of Colorado Health Science Ctr. *Not yet recruiting*
Aurora, Colorado, 80010
United States
Not yet recruiting Jennifer Maitlen 720-848-0653
Scripps Clinic: Ida M. and Cecil H. Green Cancer Center *Terminated*
La Jolla, California, 92037
United States
Terminated
Emory University Hospital *Not yet recruiting*
Atlanta, Georgia, 30322
United States
Not yet recruiting Carol Hill 404-778-4907
Florida Cancer Specialists *Not yet recruiting*
Ft. Myers, Florida, 33901
United States
Not yet recruiting Joyce Davis 239-274-9930
Southwest Regional Cancer Center *Recruiting*
Austin, Texas, 78705
United States
Recruiting Heidi Herndon 512-421-4163
Christiana Care Health Services *Not yet recruiting*
Newark, Delaware, 19713
United States
Not yet recruiting Jan Healy 302-733-6299
University of Chicago *Not yet recruiting*
Chicago, Illinois, 60637
United States
Not yet recruiting Angela Holman 773-834-1759
Additional Information:
Study ID Numbers: C023; ProMune
Study Start Date: September 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070642
Other Melanoma Studies:
1. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
2. Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
3. Novel Adjuvants for Peptide-Based Melanoma Vaccines
4. ADI-PEG in Patients With Metastatic Melanoma
5. Study of Talabostat in Advanced Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
CPG 7909 in Melanoma
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