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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00645 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 5R01CA120228 | U.S. NIH Grant/Contract | View source |
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No participants enrolled
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.
PRIMARY OBJECTIVES:
I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.
II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing sentinel lymph node biopsy.
ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
After completion of study treatment, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (sargramostim and sentinel lymph node biopsy) | Experimental | Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy. |
|
| Arm II (hypertonic saline and sentinel lymph node biopsy) | Active Comparator | Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sargramostim | Biological | Given SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of alterations in the SN | A series of analysis of variance (ANOVA) models will be employed. | Up to 30 days |
| Proportion of subjects with positive SN in each group | The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | A two sample t-test will be used. | Up to 30 days |
| Overall survival (OS) | A two sample t-test will be used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Essner | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| sentinel lymph node biopsy | Procedure | Undergo sentinel lymph node biopsy |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| hypertonic saline | Other | Given SC |
|
|
| Up to 30 days |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D021701 | Sentinel Lymph Node Biopsy |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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