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

Stage IIC Melanoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01826864
• Other study ID #: 11-002177
• Secondary ID: NCI-2013-006455R
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 5, 2011
• Est. completion date: August 8, 2017

Study information

• Verified date: March 2018
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• sargramostim
Given SC

Procedure:
• sentinel lymph node biopsy
Undergo sentinel lymph node biopsy

Other:
• laboratory biomarker analysis
Correlative studies
• hypertonic saline
Given SC

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Genzyme, a Sanofi Company, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of alterations in the SN	A series of analysis of variance (ANOVA) models will be employed.	Up to 30 days
Primary	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.	Up to 30 days
Secondary	Disease free survival (DFS)	A two sample t-test will be used.	Up to 30 days
Secondary	Overall survival (OS)	A two sample t-test will be used.	Up to 30 days