Clinical trial NCT01826864: Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Stage IB Melanoma
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: National Cancer Institute (NCI)
First posted: 2013-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reversal of alterations in the SN
timeFrame: Up to 30 days
measure: Proportion of subjects with positive SN in each group
timeFrame: Up to 30 days
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: Up to 30 days
measure: Overall survival (OS)
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Richard Essner
role: PRINCIPAL_INVESTIGATOR
References: