Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
NCT ID: NCT01826864
Last Updated: 2020-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2011-08-05
2017-08-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (sargramostim and sentinel lymph node biopsy)
Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy.
sargramostim
Given SC
sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
laboratory biomarker analysis
Correlative studies
Arm II (hypertonic saline and sentinel lymph node biopsy)
Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
laboratory biomarker analysis
Correlative studies
hypertonic saline
Given SC
Interventions
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sargramostim
Given SC
sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
laboratory biomarker analysis
Correlative studies
hypertonic saline
Given SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Richard Essner
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2013-00645
Identifier Type: REGISTRY
Identifier Source: secondary_id
11-002177
Identifier Type: -
Identifier Source: org_study_id
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