Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Inoperable Locally Advanced or Metastatic Melanoma.
1 other identifier
interventional
N/A
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2003
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedMarch 5, 2015
March 1, 2015
September 9, 2003
March 4, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed inoperable locally advanced or metastatic malignant melanoma.
- 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).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Arizona Cancer Center at Scottsdale
Scottsdale, Arizona, 85285, United States
Univ of Arizona Cancer Center
Tucson, Arizona, 85724, United States
USC / Norris Cancer Center
Los Angeles, California, 90033, United States
Cancer Institute Medical Group
Santa Monica, California, 90404, United States
Univ of Colorado Cancer Center/ Anschutz Cancer
Aurora, Colorado, 80010, United States
US Oncology / Cancer Centers of Florida
Orlando, Florida, 32806, United States
US Oncology / Kansas City Oncology
Overland Park, Kansas, 66210, United States
Beth Israel Medical Center
Boston, Massachusetts, 02215, United States
US Oncology / Kansas City Oncology and Hematology
Kansas City, Missouri, 64111, United States
Center for Cancer Care Research
St Louis, Missouri, 63141, United States
US Oncology / Albany Regional Cancer Center
Albany, New York, 12208, United States
US Oncology / Dayton Oncology and Hematology
Kettering, Ohio, 45409, United States
US Oncology / Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
US Oncology / Mary Crowley Medical Research
Dallas, Texas, 75246, United States
US Oncology /Texas Oncology
Fort Worth, Texas, 76104, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
US Oncology/ Tyler Cancer Center
Tyler, Texas, 75702, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
US Oncology / Cancer Care Northwest
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2003
First Posted
September 11, 2003
Study Start
August 1, 2003
Study Completion
January 1, 2006
Last Updated
March 5, 2015
Record last verified: 2015-03