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Sponsors and Collaborators: |
Northern California Melanoma Center Bayer Melanoma Research Institute |
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Information provided by: | Northern California Melanoma Center |
ClinicalTrials.gov Identifier: | NCT00350597 |
This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence (Stage II T4, III and IV).
Condition | Intervention | Phase |
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Malignant Melanoma |
Drug: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Immunologic and Antibody Responses in Patients Receiving GM-CSF, (Leukine, Sargramostim) as Adjuvant Therapy of Stage II (T4), III and IV Melanoma. |
Estimated Enrollment: | 50 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | July 2010 |
This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence (Stage II T4, III and IV). The immunological responses include serum neopterin levels. In a sub-set of study participants, additional immunologic testing will be done, including monocyte cytotoxicity to a melanoma cell line and phenotypic and functional markers of dendritic and T cell activation in peripheral blood mononuclear cells. The clinical end points of the study include safety, time to disease recurrence, time to disseminated disease, and survival. Eligible patients are those with high-risk melanoma who are clinically tumor free following surgery. Treatment will consist of GM-CSF at 125 g/m2 once daily (maximum dose 250 g) for 14 days followed by 14 days of rest (28 day cycle) for 1 year. Clinical status will be monitored until death or until the patient has been tumor free for five years, whichever event occurs first. Immunologic responses will be determined pretreatment, at the end of the first 14 days of dosing (Day 15), after the 14-day rest period (Day 29) and at the end of 14 days of dosing in cycles 6 (Day 155) and 13 (Day 351). Clinical outcome will be determined according to patient risk group (ultra-high risk Stage IIIC or IV versus high-risk Stage II T4, Stage IIIA and Stage IIIB). The pilot study will also assess the association of the immunological responses with clinical response and safety by patient risk group.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Northern California Melanoma Center | |
San Francisco, California, United States, 94109 |
Principal Investigator: | Lynn E. Spitler, MD | Northern California Melanoma Center |
Study ID Numbers: | GM-CSF 040906 |
Study First Received: | July 10, 2006 |
Last Updated: | July 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00350597 |
Health Authority: | United States: Institutional Review Board |
Malignant Melanoma Adjuvant Therapy Cytokine Therapy Immunologic Testing |
Neuroectodermal Tumors Antibodies Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Immunoglobulins Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |