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.
- Histologically or cytologically confirmed inoperable locally advanced or metastatic
- 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).
- 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
- 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
- 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.