Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection

Conditions
-----------------
Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma

Intervention / Treatment
-----------------
* Biological: sargramostim
* Procedure: sentinel lymph node biopsy
* Other: laboratory biomarker analysis
* Other: hypertonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage IB or II cutaneous melanoma Primaries on the torso, upper and lower extremities and head and neck region Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study Bilirubin < 2.0 ng/dl Creatinine < 3.0 ng/dl Able to understand the consent competent to sign Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: Prior wide excision with diameter of the excision > 3 cm Primary melanoma arises from the eye or mucus membranes Clinical evidence of regional, intransit ,or distant metastases Second invasive melanoma Prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (SN) Patients with primary or secondary immunodeficiencies Pregnancy Known allergy to sargramostim (GM-CSF) History of cardiac disease, in particular, supraventricular tachycardia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (sargramostim and sentinel lymph node biopsy)<br>Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy. | Biological: sargramostim<br>* Given SC<br>* Other names: Prokine;Procedure: sentinel lymph node biopsy<br>* Undergo sentinel lymph node biopsy<br>* Other names: sentinel node biopsy;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Active Comparator: Arm II (hypertonic saline and sentinel lymph node biopsy)<br>Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy. | Procedure: sentinel lymph node biopsy<br>* Undergo sentinel lymph node biopsy<br>* Other names: sentinel node biopsy;Other: laboratory biomarker analysis<br>* Correlative studies<br>Other: hypertonic saline<br>* Given SC<br>* Other names: HTS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Up to 30 days |