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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01826864
Collaborator
Genzyme, a Sanofi Company (Industry), National Cancer Institute (NCI) (NIH)
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Study Details

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
  • Biological: sargramostim
  • Procedure: sentinel lymph node biopsy
  • Other: laboratory biomarker analysis
  • Other: hypertonic saline
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.

  2. 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
Actual Enrollment :
0 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 :
Aug 5, 2011
Actual Primary Completion Date :
Aug 8, 2017
Actual Study Completion Date :
Aug 8, 2017

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 Names:
  • 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 Names:
  • sentinel node biopsy
  • Other: laboratory biomarker analysis
    Correlative studies

    Other: hypertonic saline
    Given SC
    Other Names:
  • HTS
  • Outcome Measures

    Primary Outcome Measures

    1. Reversal of alterations in the SN [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 [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) [Up to 30 days]

      A two sample t-test will be used.

    2. Overall survival (OS) [Up to 30 days]

      A two sample t-test will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • Genzyme, a Sanofi Company
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Richard Essner, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01826864
    Other Study ID Numbers:
    • 11-002177
    • NCI-2013-00645
    • 5R01CA120228
    First Posted:
    Apr 9, 2013
    Last Update Posted:
    Jul 27, 2020
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2020