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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00068211
First received: September 9, 2003
Last updated: June 19, 2008
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: ILX651
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Study Start Date: August 2003
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068211

Locations
United States, Arizona
Arizona Cancer Center at Scottsdale
Scottsdale, Arizona, United States, 85285
Univ of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
USC / Norris Cancer Center
Los Angeles, California, United States, 90033
Cancer Institute Medical Group
Santa Monica, California, United States, 90404
United States, Colorado
Univ of Colorado Cancer Center/ Anschutz Cancer
Aurora, Colorado, United States, 80010
United States, Florida
US Oncology / Cancer Centers of Florida
Orlando, Florida, United States, 32806
United States, Kansas
US Oncology / Kansas City Oncology
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Beth Israel Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
US Oncology / Kansas City Oncology and Hematology
Kansas City, Missouri, United States, 64111
Center for Cancer Care Research
St. Louis, Missouri, United States, 63141
United States, New York
US Oncology / Albany Regional Cancer Center
Albany, New York, United States, 12208
United States, Ohio
US Oncology / Dayton Oncology and Hematology
Kettering, Ohio, United States, 45409
United States, South Carolina
US Oncology / Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
US Oncology / Mary Crowley Medical Research
Dallas, Texas, United States, 75246
US Oncology /Texas Oncology
Ft. Worth, Texas, United States, 76104
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
US Oncology/ Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
US Oncology / Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Genzyme, a Sanofi Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00068211     History of Changes
Other Study ID Numbers: ILX651-211
Study First Received: September 9, 2003
Last Updated: June 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Metastatic Melanoma
Melanoma
Inoperable Locally Advanced Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 20, 2014