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Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ILX651
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Metastatic Melanoma, Melanoma, Inoperable Locally Advanced Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

  • Arizona Cancer Center at Scottsdale
  • Univ of Arizona Cancer Center
  • USC / Norris Cancer Center
  • Cancer Institute Medical Group
  • Univ of Colorado Cancer Center/ Anschutz Cancer
  • US Oncology / Cancer Centers of Florida
  • US Oncology / Kansas City Oncology
  • Beth Israel Medical Center
  • US Oncology / Kansas City Oncology and Hematology
  • Center for Cancer Care Research
  • US Oncology / Albany Regional Cancer Center
  • US Oncology / Dayton Oncology and Hematology
  • US Oncology / Cancer Centers of the Carolinas
  • US Oncology / Mary Crowley Medical Research
  • US Oncology /Texas Oncology
  • St. Luke's Episcopal Hospital
  • US Oncology/ Tyler Cancer Center
  • Seattle Cancer Care Alliance
  • US Oncology / Cancer Care Northwest

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2003
Last Updated
March 4, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00068211
Brief Title
Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Metastatic Melanoma, Melanoma, Inoperable Locally Advanced Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ILX651

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Facility Information:
Facility Name
Arizona Cancer Center at Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85285
Country
United States
Facility Name
Univ of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
USC / Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cancer Institute Medical Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Univ of Colorado Cancer Center/ Anschutz Cancer
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
US Oncology / Cancer Centers of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
US Oncology / Kansas City Oncology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Beth Israel Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
US Oncology / Kansas City Oncology and Hematology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Center for Cancer Care Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
US Oncology / Albany Regional Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
US Oncology / Dayton Oncology and Hematology
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
US Oncology / Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
US Oncology / Mary Crowley Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
US Oncology /Texas Oncology
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
US Oncology/ Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
US Oncology / Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma

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