Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
NCT ID: NCT00068211
Last Updated: 2015-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-08-31
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ILX651
Eligibility Criteria
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Inclusion Criteria
* 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.
* Male or female patients greater than or equal to 18 years of age.
* ECOG performance status of 0 or 1.
* 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: A. Absolute neutrophil count(ANC) greater than or equal to 1.5 x 1,000,000,000. B.Hemoglobin greater than or equal to 9.0 g/Dl. C. Platelet count greater than or equal to 100 x 1,000,000,000/L. E. Serum creatinine or calculated creatinine clearance less than or equal to 1.5 mg/dL or greater than or equal to 60 mL/min. F. Serum total bilirubin less than or equal to 2.0 mg/dL. G. 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. H. Alkaline phosphatase less than or equal to 5 times the ULN (unless bone metastases are present in the absence of liver metastases).
* 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.
* 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.
* Signed informed consent (includes HIPAA authorization).
Exclusion Criteria
* Previously treated with systemic chemotherapy.
* Prior radiotherapy to the only site of measurable disease.
* Known hypersensitivity to study drug or its analogs.
* 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.
* Use of investigational agents within previous 30 days.
* Known, active infection, or known HIV positive or presence of an AIDS related illness.
* Active secondary malignancy.
* 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.
* Uncontrolled hypertension. Patients with hypertension must have their blood pressure controlled on antihypertensive medications as assessed by the investigator.
* Patients with prior radiation therapy to greater than 25% of the bone marrow (eg, no whole pelvic irradiation is allowed).
* 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.
* Pregnant or lactating females.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Locations
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Arizona Cancer Center at Scottsdale
Scottsdale, Arizona, United States
Univ of Arizona Cancer Center
Tucson, Arizona, United States
USC / Norris Cancer Center
Los Angeles, California, United States
Cancer Institute Medical Group
Santa Monica, California, United States
Univ of Colorado Cancer Center/ Anschutz Cancer
Aurora, Colorado, United States
US Oncology / Cancer Centers of Florida
Orlando, Florida, United States
US Oncology / Kansas City Oncology
Overland Park, Kansas, United States
Beth Israel Medical Center
Boston, Massachusetts, United States
US Oncology / Kansas City Oncology and Hematology
Kansas City, Missouri, United States
Center for Cancer Care Research
St Louis, Missouri, United States
US Oncology / Albany Regional Cancer Center
Albany, New York, United States
US Oncology / Dayton Oncology and Hematology
Kettering, Ohio, United States
US Oncology / Cancer Centers of the Carolinas
Greenville, South Carolina, United States
US Oncology / Mary Crowley Medical Research
Dallas, Texas, United States
US Oncology /Texas Oncology
Fort Worth, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
US Oncology/ Tyler Cancer Center
Tyler, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
US Oncology / Cancer Care Northwest
Spokane, Washington, United States
Countries
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Other Identifiers
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ILX651-211
Identifier Type: -
Identifier Source: org_study_id
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