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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stage IIB Melanoma; Stage IIC Melanoma; Stage IB Melanoma; Stage IIA Melanoma
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: sentinel lymph node biopsy; Biological: sargramostim; Other: hypertonic saline

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); Genzyme, a Sanofi Company
• Investigators: Principal Investigator: Richard Essner, Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2011
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): August 8, 2017

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Immunologic Factors; Sargramostim
• Other Study ID Numbers: 11-002177; NCI-2013-00645 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 5R01CA120228 (U.S. NIH Grant/Contract)