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

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ClinicalTrials.gov Identifier: NCT01826864
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stage IB Melanoma Stage IIA Melanoma Stage IIB Melanoma Stage IIC Melanoma Biological: sargramostim Procedure: sentinel lymph node biopsy Other: laboratory biomarker analysis Other: hypertonic saline Phase 3

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 Design

Study Type : Interventional
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
Actual Study Start Date : August 5, 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma
U.S. FDA Resources

Arms and Interventions

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.
Biological: sargramostim
Given SC
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Name: sentinel node biopsy
Other: laboratory biomarker analysis
Correlative studies
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.
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Name: sentinel node biopsy
Other: laboratory biomarker analysis
Correlative studies
Other: hypertonic saline
Given SC
Other Name: HTS


Outcome Measures

Primary Outcome Measures :
  1. Reversal of alterations in the SN [ Time Frame: Up to 30 days ]
    A series of analysis of variance (ANOVA) models will be employed.

  2. Proportion of subjects with positive SN in each group [ Time Frame: 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 :
  1. Disease free survival (DFS) [ Time Frame: Up to 30 days ]
    A two sample t-test will be used.

  2. Overall survival (OS) [ Time Frame: Up to 30 days ]
    A two sample t-test will be used.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826864


Locations
United States, California
Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Richard Essner    310-825-5268    ressner@mednet.ucla.edu   
Principal Investigator: Richard Essner         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Richard Essner Jonsson Comprehensive Cancer Center
More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01826864     History of Changes
Other Study ID Numbers: 11-002177
NCI-2013-00645 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas