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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Jonsson Comprehensive Cancer Center
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01826864
First received: April 4, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Reversal of alterations in the SN [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    A series of analysis of variance (ANOVA) models will be employed.

  • Proportion of subjects with positive SN in each group [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.


Secondary Outcome Measures:
  • Disease free survival (DFS) [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    A two sample t-test will be used.

  • Overall survival (OS) [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    A two sample t-test will be used.


Estimated Enrollment: 380
Study Start Date: August 2011
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01826864     History of Changes
Other Study ID Numbers: 11-002177, NCI-2013-00645, 11-002177
Study First Received: April 4, 2013
Last Updated: September 8, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014