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Sponsor: Jonsson Comprehensive Cancer Center
Conditions: Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma
Interventions: sargramostim, sentinel lymph node biopsy, laboratory biomarker analysis, hypertonic saline
Countries: United States
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.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Los Angeles, California, United States