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

NCT01826864 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-27

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Richard Essner · Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-05
Primary Completion
2017-08-08
Completion
2017-08-08

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01826864 on ClinicalTrials.gov