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Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma Clinical research trials and Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma. Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma clinical trial. Subjects typically recieve the finest healthcare available for their Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma  Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma
Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): ILEX Products ,
Synopsis: This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate for all patients who are treated with ILX651. The secondary objectives are to determine the progression free survival at 18 weeks, duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and to evaluate the pharmacokinetic profile.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: (1) Histologically or cytologically confirmed inoperable locally advanced or metastatic malignant melanoma. (2) Measurable disease. Measurable lesions should be outside the field of radiation. Where measurable lesions are within a previously irradiated field, there must be objective evidence of progression of the lesion prior to patient enrollment. (3) Male or female patients greater than or equal to 18 years of age. (4) ECOG performance status of 0 or 1. (5) Must have adequate organ and immune system function as indicated by the following laboratory values, obtained less than or equal to 2 weeks prior to registration: - Absolute neutrophil count(ANC) greater than or equal to 1.5 x 1,000,000,000 - Hemoglobin greater than or equal to 9.0 g/dL - Platelet count greater than or equal to 100 x 1,000,000,000/L - Serum creatinine or calculated creatinine clearance less than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min - Serum total bilirubin less than or equal to 2.0 mg/dL - AST and ALT less than or equal to 3 times the upper limit of normal (ULN) OR less than 5 times the ULN if secondary to liver metastases - Alkaline phosphatase less than or equal to 5 times the ULN (unless bone metastases are present in the absence of liver metastases) (6) Anti-cancer therapy, major surgery, or irradiation must have been completed at least 4 weeks before enrollment in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy. (7) Female patients with childbearing potential must have a negative pregnancy test within 7 days of study enrollment. Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study. (8) Signed informed consent (includes HIPAA authorization). Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study admission: (1) Patients with uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification. (2) Previously treated with systemic chemotherapy. (3) Prior radiotherapy to the only site of measurable disease. (4) Known hypersensitivity to study drug or its analogs. (5) Active ocular melanoma. Patients with a primary diagnosis of ocular melanoma will not be excluded provided the primary ocular melanoma is no longer present and the recurrence is distal. (6) Use of investigational agents within previous 30 days. (7) Known, active infection, or known HIV positive or presence of an AIDS related illness. (8) Active secondary malignancy. (9) Presence of symptomatic active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis is permitted only if the patient has been in clinical complete remission for at least 1 month after therapy. (10) Uncontrolled hypertension. Patients with hypertension must have their blood pressure controlled on antihypertensive medications as assessed by the investigator. (11) Patients with prior radiation therapy to greater than 25% of the bone marrow (eg, no whole pelvic irradiation is allowed). (12) Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results. (13) Pregnant or lactating females.
Total Enrollment: 60
Location and Contact Information:
US Oncology / Cancer Centers of the Carolinas *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Sebrina Madden 864-241-6251
US Oncology / Kansas City Oncology and Hematology *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Mary Rogers 816-531-2740
US Oncology / Cancer Care Northwest *Recruiting*
Spokane, Washington, 99218
United States
Recruiting Rosalee Miller 509-464-5120
US Oncology / Albany Regional Cancer Center *Recruiting*
Albany, New York, 12208
United States
Recruiting Michelle Butler 518-489-2607
Univ of Arizona Cancer Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Susan Jordan 520-626-2263
US Oncology / Kansas City Oncology *Recruiting*
Overland Park, Kansas, 66210
United States
Recruiting Vickie Thomas 913-541-4641
US Oncology /Texas Oncology *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Suzanne Graham 817-850-2000
Seattle Cancer Care Alliance *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Jennifer Revall 206-288-2041
Arizona Cancer Center at Scottsdale *Recruiting*
Scottsdale, Arizona, 85285
United States
Recruiting Molly Downhour 480-657-1357
Center for Cancer Care Research *Recruiting*
St. Louis, Missouri, 63141
United States
Recruiting Kelli Martin 314-628-1200
US Oncology/ Tyler Cancer Center *Recruiting*
Tyler, Texas, 75702
United States
Recruiting Linda Dunklin 903-579-9800
US Oncology / Mary Crowley Medical Research *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Dawn Rich 214-370-1780
USC / Norris Cancer Center *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Jolie Snively 323-865-0464
US Oncology / Dayton Oncology and Hematology *Recruiting*
Kettering, Ohio, 45409
United States
Recruiting Michelle Owens 937-293-1622
Cancer Institute Medical Group *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Patricia Ames 310-582-7974
US Oncology / Cancer Centers of Florida *Recruiting*
Orlando, Florida, 32806
United States
Recruiting Patricia Innis-DeLeon 407-426-8484
Univ of Colorado Cancer Center/ Anschutz Cancer *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Jennifer Maitlen 720-848-0653
Beth Israel Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Melissa Langfield 617-667-1917
St. Luke's Episcopal Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting Deborah Otto 832-355-7110
Additional Information:
Study ID Numbers: ILX651-211;
Study Start Date: August 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068211
Other Melanoma Studies:
1. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
2. Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
3. Flt3L and CD40L to Treat Metastatic Melanoma and Kidney Cancer
4. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
5. A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
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Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma
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