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Arm I (sargramostim and sentinel lymph node biopsy) for Melanoma

Phase 3
Waitlist Available
Led By Richard Essner
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights

Study 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.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects with positive SN in each group
Reversal of alterations in the SN
Secondary outcome measures
Disease free survival (DFS)
Overall survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (sargramostim and sentinel lymph node biopsy)Experimental Treatment3 Interventions
Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Group II: Arm II (hypertonic saline and sentinel lymph node biopsy)Active Control3 Interventions
Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sentinel lymph node biopsy
2013
Completed Phase 3
~5720
Sargramostim
FDA approved

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,748 Total Patients Enrolled
19 Trials studying Melanoma
627 Patients Enrolled for Melanoma
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,620 Total Patients Enrolled
6 Trials studying Melanoma
117 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,729 Total Patients Enrolled
559 Trials studying Melanoma
195,442 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
2011. "Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01826864.
~0 spots leftby May 2025
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