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

Phase 3

Withdrawn

• Conditions: Stage IIC Melanoma; Stage IB Melanoma; Stage IIB Melanoma; Stage IIA Melanoma
• Interventions: Procedure: sentinel lymph node biopsy; Biological: sargramostim; Other: laboratory biomarker analysis; Other: hypertonic saline

• Registration Number: NCT01826864
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2011-08-05
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Primary Completion: 2017-08-08
• Study Completion: 2017-08-08
• Status Verified: 2018-03
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (sargramostim and sentinel lymph node biopsy)	laboratory biomarker analysis	Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Arm II (hypertonic saline and sentinel lymph node biopsy)	sentinel lymph node biopsy	Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Arm II (hypertonic saline and sentinel lymph node biopsy)	hypertonic saline	Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Arm I (sargramostim and sentinel lymph node biopsy)	sargramostim	Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Arm I (sargramostim and sentinel lymph node biopsy)	sentinel lymph node biopsy	Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Arm II (hypertonic saline and sentinel lymph node biopsy)	laboratory biomarker analysis	Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.

Primary Outcome Measures

Name	Time	Method
Reversal of alterations in the SN	Up to 30 days	A series of analysis of variance (ANOVA) models will be employed.
Proportion of subjects with positive SN in each group	Up to 30 days	The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 30 days	A two sample t-test will be used.
Disease free survival (DFS)	Up to 30 days	A two sample t-test will be used.

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States