Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma
OBJECTIVES:
Primary
- Assess the activity of paclitaxel and sargramostim (GM-CSF), in terms of objective
clinical response rate (complete response [CR] and partial response [PR]), in patients
with advanced unresectable melanoma.
Secondary
- Evaluate the duration of response, time to progression, and overall survival of
patients treated with this regimen.
- Determine serum cytokine levels (GM-CSF, IFN-γ, aldesleukin, recombinant interleukin-4,
and IL-10) in these patients.
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV over 3 hours on day 1 and sargramostim (GM-CSF)
subcutaneously on days 4-17. Treatment repeats every 21 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity. Patients achieving complete
response (CR) receive 2 additional courses of therapy beyond CR for up to 12 courses.
After study treatment, patients are followed every 3-6 months for at least 3 years.
PROJECTED ACCRUAL: A total of 42 patients will accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Clinical response by CT scans every 6 weeks
No
William W. Grosh, MD
Principal Investigator
University of Virginia
United States: Food and Drug Administration
CDR0000450798
NCT00278122
July 2005
Name | Location |
---|---|
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |