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

Withdrawn before enrolling · Phase 3

Conditions studied: Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma

In brief

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.

Key facts

Study ID

NCT01826864

Run by

Jonsson Comprehensive Cancer Center

People needed

0

Starts

2011-08-05

Expected to finish

2017-08-08

Last updated by the study team

2020-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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