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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01826864

Enrollment

Registered

2013-04-09

Start date

2011-08-05

Completion date

2017-08-08

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma

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.

Interventions

BIOLOGICALsargramostim

Given SC

PROCEDUREsentinel lymph node biopsy

Undergo sentinel lymph node biopsy

OTHERlaboratory biomarker analysis

Correlative studies

OTHERhypertonic saline

Given SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026