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Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma Clinical research trials and Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma. Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma clinical trial. Human subjects often receive the most effective healthcare possible for their Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma  Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
For Condition: Malignant Metastatic Melanoma,Melanoma
Status: Recruiting
Sponsor(s): MedImmune, Inc. ,
Synopsis: The primary objectives of this study are: - To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma. - To determine the safety of MEDI-522 ± DTIC in this patient population.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Patients must meet all of the following criteria at the time of randomization: - Histologically confirmed, unresectable, Stage IV metastatic melanoma (AJCC staging), with at least one measurable lesion defined as 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 computed tomography (CT) scan; - Adult men and women of at least 18 years of age at the time of randomization; - Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum β human chorionic gonadotropin (βhCG) pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), condom, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) at the time the informed consent is signed, and must agree to continue using such precautions while receiving MEDI-522 and for 30 days after the final dose of MEDI-522; - Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1; - Life expectancy of at least 16 weeks; - WBC 3,000/mm3, absolute neutrophil count (ANC) 1,500/mm3, platelet count 100,000/mm3; - Bilirubin 1.5 mg/dL, aspartate transaminase (AST)/alanine transaminase (ALT) 3 times upper limit of normal (ULN), serum creatinine 1.5 mg/dL, alkaline phosphatase 3.0 times ULN and prothrombin time (PT)/partial thromboplastin time (PTT) or international normalized ratio (INR) within normal range; - Patients who have had prior treatment with adjuvant immunotherapy are eligible for study randomization provided that therapy ended at least 4 weeks prior to randomization; - Patients who had prior surgery are eligible if at least 4 weeks have passed since their surgery; - All toxicities related to prior adjuvant therapy must have resolved and all surgical wounds must have healed; - Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures. Exclusion Patients must have none of the following at the time of randomization: - Pregnancy or nursing; - Prior therapy for metastatic melanoma including chemotherapy, radiotherapy, hormonal therapy, or biologics; - Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer; - Current or planned participation (from the day of randomization through 30 days after the last dose of MEDI-522) in a research protocol in which an investigational agent or therapy may be administered; - Received an investigational agent within 4 weeks prior to randomization; - Known brain metastases or primary brain tumors, ocular melanoma, symptomatic pleural effusion or ascites requiring paracentesis; - History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer; - History of pulmonary embolus. - Active thrombophlebitis. - Currently requiring therapeutic anticoagulation. - Any evidence of hematemesis, melena, hematochezia, or gross hematuria; - History or presence of bleeding diatheses; - Elective surgery planned during the study period through 30 days after the last dose of MEDI-522. - History of hypersensitivity to a previously administered monoclonal antibody. - History of hypersensitivity to DTIC; - History of immunodeficiency; - Known human immunodeficiency virus (HIV) or known active viral hepatic infections; - A prior myocardial infarction or angina, or uncontrolled/refractory hypertension within 6 months prior to randomization; - A prior stroke or transient ischemic attack within the past 6 months; - An active infection requiring systemic antiinfective therapy; - Prior treatment with MEDI-522 or MEDI-523; - A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.
Total Enrollment:
Location and Contact Information:
HemOnc Care, P.C. *Recruiting*
Brooklyn, New York, 11235
United States
Recruiting Fakhiuddin Ahmad 718-616-0801
Kansas City Oncology & Hematology Group *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Kelly Pendergrass 816-333-1326
Medical Group of North County *Recruiting*
Vista, California, 92083
United States
Recruiting Edward McClay 760-598-1700
Indiana University Medical Center *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Theodore Logan 317-274-0932
Yale University School of Medicine *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting Harriett Kluger 203-785-6221
Johns Hopkins University - SKCC at Johns Hopkins *Recruiting*
Lutherville, Maryland, 21093
United States
Recruiting William Sharfman 410-583-2970
The University of Texas, MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Agop Bedikian 713-794-4458
Thomas Jefferson University *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Takami Sato 215-955-6923
Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Adam Lerner 617-638-7504
Providence Portland Medical Center *Recruiting*
Portland, Oregon, 97213
United States
Recruiting Walter Urba 503-215-6805
Indiana Oncology Hematology Consultants *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Khuda Khan 317-833-1297
Oncology Specialists, S.C. *Recruiting*
Park Ridge, Illinois, 60069
United States
Recruiting Jon Richards 847-268-8200
UNC-Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting David Ollila 919-966-5439
The Melanoma Center of St. Louis *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Eric Whitman 314-991-4644
Saint Francis Memorial Hospital *Recruiting*
San Francisco, California, 94109
United States
Recruiting Robert Weber 415-353-6863
Cancer Institute Medical Group *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Steven O'Day 310-998-3943
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Paul Chapman 212-639-5015
University of Miami *Recruiting*
Miami, Florida, 33136
United States
Recruiting Lynn Faun 305-243-4981
Pacific Shores Medical Group *Recruiting*
Long Beach, California, 90813
United States
Recruiting N. Tchekmedyian 562-590-0345
Blumenthal Cancer Center *Recruiting*
Charlotte, North Carolina, 28203
United States
Recruiting Gary Frenette 704-446-9040
University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting John Kirkwood 412-692-4724
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting David Lawson 404-778-1900
Discovery Alliance *Recruiting*
Houston, Texas, 77030
United States
Recruiting H. Preti 713-363-7995
Mayo Clinic Arizona *Recruiting*
Scottsdale, Arizona, 85259
United States
Recruiting Michael Gornet 480-301-8000
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Jeffrey Sosman 615-936-1515
Additional Information:
Study ID Numbers: MI-CP095;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066196
Other Melanoma Studies:
1. Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
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Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
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