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

Information source: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage IB Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma

Intervention: sargramostim (Biological); sentinel lymph node biopsy (Procedure); laboratory biomarker analysis (Other); hypertonic saline (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Jonsson Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Richard Essner, Principal Investigator, Affiliation: Jonsson Comprehensive Cancer Center


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.

Clinical Details

Official title: Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Reversal of alterations in the SN

Proportion of subjects with positive SN in each group

Secondary outcome:

Disease free survival (DFS)

Overall survival (OS)

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 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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Jonsson Comprehensive Cancer Center, Los Angeles, California 90095, United States; Recruiting
Richard Essner, Phone: 310-825-5268, Email: ressner@mednet.ucla.edu
Richard Essner, Principal Investigator
Additional Information

Starting date: August 2011
Last updated: April 8, 2015

Page last updated: August 23, 2015

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