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

NCT01826864 | Withdrawn Phase 3 DMC

• 3 other identifiers: 11-002177NCI-2013-006455R01CA120228
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IB Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma

Outcome Measures

Primary Outcomes (2)

• Reversal of alterations in the SN

  A series of analysis of variance (ANOVA) models will be employed.

  Up to 30 days

• 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 Outcomes (2)

• Disease free survival (DFS)

  Up to 30 days

• Overall survival (OS)

  Up to 30 days

Study Arms (2)

Arm I (sargramostim and sentinel lymph node biopsy)

EXPERIMENTAL

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

Biological: sargramostim; Procedure: sentinel lymph node biopsy; Other: laboratory biomarker analysis

Arm II (hypertonic saline and sentinel lymph node biopsy)

ACTIVE COMPARATOR

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

Procedure: sentinel lymph node biopsy; Other: laboratory biomarker analysis; Other: hypertonic saline

Interventions

sargramostim BIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine

Arm I (sargramostim and sentinel lymph node biopsy)

sentinel lymph node biopsy PROCEDURE

Undergo sentinel lymph node biopsy

Also known as: sentinel node biopsy

Arm I (sargramostim and sentinel lymph node biopsy); Arm II (hypertonic saline and sentinel lymph node biopsy)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (sargramostim and sentinel lymph node biopsy); Arm II (hypertonic saline and sentinel lymph node biopsy)

hypertonic saline OTHER

Given SC

Also known as: HTS

Arm II (hypertonic saline and sentinel lymph node biopsy)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Sentinel Lymph Node Biopsy; Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Richard Essner

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: August 5, 2011
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: July 27, 2020

Record last verified: 2018-03

Locations

US (1)