Status:
WITHDRAWN
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
Conditions:
Stage IB Melanoma
Stage IIA Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 wit...
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01826864
Start Date
August 5 2011
End Date
August 8 2017
Last Update
July 27 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095