Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00278122|
Recruitment Status : Suspended
First Posted : January 18, 2006
Last Update Posted : December 10, 2013
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in treating melanoma.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: sargramostim Drug: paclitaxel||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma|
|Study Start Date :||July 2005|
|Estimated Primary Completion Date :||December 2015|
- Clinical response by CT scans every 6 weeks
- Duration of response by CT scans every 6 weeks
- Time to progression by CT scans every 6 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278122
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||William W. Grosh, MD||University of Virginia|