NCT01826864

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage IB Melanoma
• Stage IIA Melanoma
• Stage IIB Melanoma
• Stage IIC Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim	Given SC
PROCEDURE	sentinel lymph node biopsy	Undergo sentinel lymph node biopsy
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	hypertonic saline	Given SC

Timeline

• Start date: 2011-08-05
• Primary completion: 2017-08-08
• Completion: 2017-08-08
• First posted: 2013-04-09
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States