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

Primary Purpose

Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sargramostim
sentinel lymph node biopsy
laboratory biomarker analysis
hypertonic saline
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IB Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (sargramostim and sentinel lymph node biopsy)

Arm II (hypertonic saline and sentinel lymph node biopsy)

Arm Description

Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.

Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.

Outcomes

Primary Outcome Measures

Reversal of alterations in the SN
A series of analysis of variance (ANOVA) models will be employed.
Proportion of subjects with positive SN in each group
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)
A two sample t-test will be used.
Overall survival (OS)
A two sample t-test will be used.

Full Information

First Posted
April 4, 2013
Last Updated
July 23, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Genzyme, a Sanofi Company, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01826864
Brief Title
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
August 5, 2011 (Actual)
Primary Completion Date
August 8, 2017 (Actual)
Study Completion Date
August 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Genzyme, a Sanofi Company, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (sargramostim and sentinel lymph node biopsy)
Arm Type
Experimental
Arm Description
Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Arm Title
Arm II (hypertonic saline and sentinel lymph node biopsy)
Arm Type
Active Comparator
Arm Description
Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
Intervention Type
Biological
Intervention Name(s)
sargramostim
Other Intervention Name(s)
GM-CSF, Leukine, Prokine
Intervention Description
Given SC
Intervention Type
Procedure
Intervention Name(s)
sentinel lymph node biopsy
Other Intervention Name(s)
sentinel node biopsy
Intervention Description
Undergo sentinel lymph node biopsy
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
hypertonic saline
Other Intervention Name(s)
HTS
Intervention Description
Given SC
Primary Outcome Measure Information:
Title
Reversal of alterations in the SN
Description
A series of analysis of variance (ANOVA) models will be employed.
Time Frame
Up to 30 days
Title
Proportion of subjects with positive SN in each group
Description
The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
A two sample t-test will be used.
Time Frame
Up to 30 days
Title
Overall survival (OS)
Description
A two sample t-test will be used.
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Essner
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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