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Sponsors and Collaborators: |
University of Virginia National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278122 |
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 | Intervention | Phase |
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Melanoma (Skin) |
Drug: paclitaxel Drug: sargramostim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma |
Estimated Enrollment: | 42 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable stage III or IV melanoma from a cutaneous, mucosal, or unknown primary site
Unresectable stage III disease, defined as meeting 1 of the following criteria:
Patients with brain metastases may be eligible if all of the following are true:
Each brain metastasis has been completely removed by surgery or each unresected brain metastasis has been treated with stereotactic radiosurgery
PATIENT CHARACTERISTICS:
No autoimmune disorder with visceral involvement
The following conditions are allowed:
PRIOR CONCURRENT THERAPY:
United States, Virginia | |
University of Virginia Cancer Center | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | William W. Grosh, MD | University of Virginia |
Responsible Party: | University of Virginia Cancer Center ( William W. Grosh ) |
Study ID Numbers: | CDR0000450798, UVACC-MEL-46, UVACC-HIC-11782, UVACC-HIT-028.8, UVACC-GCRC-WWG002, UVACC-PRC-350-04 |
Study First Received: | January 16, 2006 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00278122 |
Health Authority: | United States: Food and Drug Administration |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Paclitaxel Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Neoplasms, Nerve Tissue Nevi and Melanomas Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |