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

Jonsson Comprehensive Cancer Center

Status and phase: Withdrawn; Phase 3

Conditions: Stage IIB Melanoma; Stage IB Melanoma; Stage IIC Melanoma; Stage IIA Melanoma

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01826864

5R01CA120228 (U.S. NIH Grant/Contract)

11-002177

NCI-2013-00645 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm I (sargramostim and sentinel lymph node biopsy)

Experimental group

Description:

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

Treatment:

Procedure: sentinel lymph node biopsy

Other: laboratory biomarker analysis

Biological: sargramostim

Arm II (hypertonic saline and sentinel lymph node biopsy)

Active Comparator group

Description:

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

Treatment:

Procedure: sentinel lymph node biopsy

Other: laboratory biomarker analysis

Other: hypertonic saline