Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jonsson Comprehensive Cancer Center
With
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
